AccessGUDID - DEVICE: Atala-Steinbock (00827002152328)

GUDID

Device Identifier (DI) Information

Brand Name: Atala-Steinbock
Version or Model: G15232
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 118014
Company Name: COOK INCORPORATED

Primary DI Number: 00827002152328
Issuing Agency: GS1
Commercial Distribution End Date: August 17, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 042823948 *Terms of Use

Device Description: Atala-Steinbock Balloon Follower

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):	Yes
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

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38821	Endoscopic-access dilator, single-use	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOE	DILATOR, URETHRAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dark, dry, cool place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f78db759-4895-4a1c-81de-479b8ce74f9d
Public Version Date: June 11, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016