AccessGUDID - DEVICE: Digitex (05708932503983)

GUDID

Device Identifier (DI) Information

Brand Name: Digitex
Version or Model: 52030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 52030
Company Name: Coloplast A/S

Primary DI Number: 05708932503983
Issuing Agency: GS1
Commercial Distribution End Date: July 10, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Absorbable Suture Cartridge with Needle - Polydioxanone

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?
16584	Polyester suture, bioabsorbable, monofilament, non-antimicrobial	A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NEW	SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120284	000

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: Keep out of sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Suture Diameter is 0-0 USP

Device Record Status

Public Device Record Key: 5c526ae3-459f-4a00-8a12-6f8205afc437
Public Version Date: July 12, 2024
Public Version Number: 7
DI Record Publish Date: October 28, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05708932503990	12	05708932503983	2024-07-10	Not 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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