DEVICE: Polysorb (10884521768086)

Device Identifier (DI) Information

Polysorb
X1393
Not in Commercial Distribution

Covidien LP
10884521768086
GS1
February 12, 2021
1
058614483 *Terms of Use
Coated Braided Synthetic Absorbable Suture
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
17471 Polyester suture, bioabsorbable, multifilament, non-antimicrobial
A multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester 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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GAM SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 130 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 36 Inch
Device Size Text, specify: diameter,0,N/A;
CLOSE

Device Record Status

1bb55333-3e45-4fe9-83c8-d6b919d37a6f
June 24, 2025
9
August 10, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20884521768083 36 10884521768086 2021-02-12 Not in Commercial Distribution CASE
CLOSE

Secondary DI

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

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
CLOSE