AccessGUDID - DEVICE: Coloplast (05708932752558)

GUDID

Device Identifier (DI) Information

Brand Name: Coloplast
Version or Model: 12814
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12814
Company Name: Coloplast A/S

Primary DI Number: 05708932752558
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: No description.

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):	No
Over the Counter (OTC):	Yes
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?
31987	Colostomy rod	A device that is placed through a loop of colon brought out through the abdominal wall to temporarily keep it from sliping back through the surgical opening during the loop colostomy procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZP	Rod, colostomy

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: Do not use if package is damaged and consult IFU.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b59cde1-2ffe-432e-ad4f-396a4a306dd8
Public Version Date: January 03, 2023
Public Version Number: 1
DI Record Publish Date: December 26, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05708932651349	10	05708932752558		In Commercial Distribution	Retail Box
05708932651356	16	05708932651349		In Commercial Distribution	Shipper Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)533-0464
Email: healthcarecs@coloplast.com

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