DEVICE: Digitex (05708932504072)

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Device Identifier (DI) Information

Digitex
52033
52033
Coloplast A/S
05708932504072
GS1
1
Absorbable Suture Cartridge with Needle - Polyglycolic Acid Coated
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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
Polyglycolic acid suture A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is 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; it may be coated with a material such as polycaprolactone or uncoated. The thread provides 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
GAM SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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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 Status

In Commercial Distribution
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
05708932504089 12 05708932504072 In Commercial Distribution Retail Box
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Secondary DI

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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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