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Cook Medical G14185 - SET, URETHRAL DILATOR SET, EACH

Cook Medical # G14185 - SET, URETHRAL DILATOR SET, EACH
Part Number Cook Medical G14185
SKU Number CIA2250936
Sell Unit EACH
Ships Within 24 Hours
List Price $710.24
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Product Description

Cook Medical G14185 - SET, URETHRAL DILATOR SET, EACH

Urethral Dilator Set

Used for urethral dilation. Intended for one-time use.

Order NumberReference Part NumberFrLength (cm)
G141850737018.0 - 24.037

Components

  • Dilators 8, 10, 12, and 14 Fr, with sideports, 37 cm long, polyethylene4
  • Dilators 16, 18, 20, 22, and 24 Fr, without sideports, 37 cm long, polyethylene5
  • Straight safety wire guide .038 inch (.097 mm) diameter, stainless steel, 80 cm long wire guide with red safety index mark 39 cm from distal tip

NOTE: Prior to use, immerse AQ dilators in sterile water or isotonic saline to allow the hydrophilic surface to absorb water and become lubricious. This will ease placement under standard conditions.
CAUTION: Sterile if the package is unopened or undamaged. Do not use if package is broken.
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Suggested Instructions for Using Urethral Dilator Set

  • Advance the wire guide directly from the enclosed holder.
  • Introduce the flexible tip of the wire guide into the urethral meatus, and gently manipulate it beyond the obstruction and into the bladder. (The safety index mark, 39 cm from the wire guides flexible tip, will be externally visible under normal circumstances.)
    NOTE: The wire guide can also be placed through a cystoscope and maintained in position as the scope is removed.
  • Progressing from the smallest to the largest appropriate size, pass the radiopaque dilators over the wire guide while maintaining the wire guides position.

CAUTION: Do not advance dilators beyond the 39 cm safety index mark. When the end of the dilator is at the mark, a 2 cm length of wire protrudes from the tip. Further advancement of the dilator will override the wire guide.

Device Characteristics

What MRI safety information does the labeling contain?Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):No
Device labeled as "Not made with natural rubber latex":No
For Single-Use:Yes
Prescription Use (Rx):Yes
Over the Counter (OTC):No
Kit:No
Combination Product:No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):No


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