DEVICE: Reli (00386120007229)

Device Identifier (DI) Information

Reli
ML397-SI
In Commercial Distribution

MYCO MEDICAL SUPPLIES INC.
00386120007229
GS1

1
879187821 *Terms of Use
REDIDIOX Monofilament Polydioxanone, Violet, 4-0, MFS-2
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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
Polyester suture, bioabsorbable, monofilament A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) 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 needle. 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.
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FDA Product Code

[?]
Product Code Product Code Name
NEW Suture, Surgical, Absorbable, Polydioxanone
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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
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Storage and Handling

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

[?]
Size Type Text
Length: 27 Inch
Device Size Text, specify: 4-0 USP
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Device Record Status

7b43e934-8168-4761-a8ec-067d0f8966d9
February 07, 2019
3
August 20, 2016
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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
20386120007223 30 10386120007226 In Commercial Distribution Case
10386120007226 12 00386120007229 In Commercial Distribution Inner Carton
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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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