DEVICE: SINUSORB® PGA (03661522015100)

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Device Record History
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Device Identifier (DI) Information
SINUSORB® PGA
8133
In Commercial Distribution

PETERS SURGICAL
03661522015100
GS1

1
265741780 *Terms of Use
No description.
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Device Characteristics
MR Safe
No
No
Yes
No
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
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FDA Product Code

[?]
Product Code Product Code Name
GAM SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K062366 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
01964f59-208a-4063-b7b8-0d43e6a9868f
July 12, 2023
4
January 09, 2020
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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
13661522015107 12 03661522015100 In Commercial Distribution
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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

[?]
No Customer Contact currently defined
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