DEVICE: Digitex (05708932504010)

Device Identifier (DI) Information

Digitex
52031
In Commercial Distribution
52031
Coloplast A/S
05708932504010
GS1

1
305524696 *Terms of Use
Absorbable Suture Cartridge with Needle - Polydioxanone
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polydioxanone suture A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polydioxanone (PDS) [made from poly (p-dioxanone)] intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
NEW SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K120284 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep out of sunlight
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Suture Diameter is 2-0 USP
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Device Record Status

b5d146ed-2c43-474b-b017-acabd27b75da
July 06, 2018
3
October 28, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05708932504027 12 05708932504010 In Commercial Distribution Retail Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)258-3476
urology@coloplast.com
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