DEVICE: Henry Schein (00304040039656)

Device Identifier (DI) Information

Henry Schein
5700471
In Commercial Distribution
5700471
HENRY SCHEIN, INC.
00304040039656
GS1

1
012430880 *Terms of Use
Suture Prolene Mono Blu DSM16
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Polypropylene suture A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polypropylene, an isostatic crystalline stereoisomer of a linear propylene polymer, 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 temporary wound support until the wound sufficiently heals to withstand normal stress; as the material does not adhere to tissues, it is typically used in cases where the suture is to be removed after healing. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
GAW SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131224 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 5-0 USP
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Device Record Status

6396d449-a3f2-4167-aa3e-a1d7c16ca6e7
July 06, 2018
3
January 10, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10304040039653 12 00304040039656 In Commercial Distribution
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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