DEVICE: Henry Schein (00304040039663)

Device Identifier (DI) Information

Henry Schein
5700472
In Commercial Distribution
5700472
HENRY SCHEIN, INC.
00304040039663
GS1

1
012430880 *Terms of Use
Suture Prolene Mono Blu DSCM13
CLOSE

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
Polyolefin suture, monofilament A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., 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 temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GAW SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131224 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 6-0 USP
CLOSE

Device Record Status

a2916d5f-2899-4875-a906-cd11035125b2
February 07, 2019
4
January 10, 2017
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
10304040039660 12 00304040039663 In Commercial Distribution
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)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE