AccessGUDID - DEVICE: Porges Coloplast (03600040325056)

GUDID

Device Identifier (DI) Information

Brand Name: Porges Coloplast
Version or Model: BD3010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BD3010
Company Name: Coloplast A/S

Primary DI Number: 03600040325056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: In-Ka® Percutaneous Balloon Dilatation Catheter Balloon dilation catheter for percutaneous access

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":	Yes
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
LJE	CATHETER, NEPHROSTOMY

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 away from light in a cool and dry place

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 10 Millimeter
Length: 55 Centimeter

Device Record Status

Public Device Record Key: 1549dbbe-da23-4200-8389-5b338e9a2a37
Public Version Date: February 01, 2021
Public Version Number: 1
DI Record Publish Date: January 22, 2021