AccessGUDID - DEVICE: Insertion Tool (05708932767521)

GUDID

Device Identifier (DI) Information

Brand Name: Insertion Tool
Version or Model: NTER01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NTER01
Company Name: COLOPLAST CORP.

Primary DI Number: 05708932767521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 847436391 *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):	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?
61944	Guidewire holder	A sterile tubular device intended to be used for the storage and retrieval of one or more guidewires within the sterile field during a procedure. It is typically a long (approximately three metres) tube, that can be secured to surgical drapes, with a funnel-shaped proximal end and sometimes a sealed, vented distal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGZ	ACCESSORIES, CATHETER

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: Keep away from rain. Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter Inner - Fr 3.1

Device Record Status

Public Device Record Key: 884ab3ce-6d3b-4be2-a572-afe13dd5b620
Public Version Date: October 07, 2024
Public Version Number: 1
DI Record Publish Date: September 27, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05708932767545	8	05708932767538		In Commercial Distribution	Shipper Box
05708932767538	35	05708932767521		In Commercial Distribution	Retail 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)258-3476
Email: urology@coloplast.com

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