DEVICE: RELI (00386120006314)

Device Identifier (DI) Information

RELI
PT1001-SI
In Commercial Distribution

MYCO MEDICAL SUPPLIES INC.
00386120006314
GS1

1
879187821 *Terms of Use
REDIBOND Coated Polyester, Green, 3-0, MC-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 A sterile, multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of polyester (a polymer of polyethylene terephthalate) fibres, that may be coated (e.g., with polybutilate/silicone), intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may also include an attached disposable needle or preloaded pledget for enhanced support. It is commonly used for vessel anastomosis and the placement of prosthetic materials, and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it elicits minimal tissue reaction and lasts indefinitely in the body. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
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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: 18 Inch
Device Size Text, specify: 3-0 USP
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Device Record Status

98ff31ed-08f8-4a63-81ac-9013e45ed266
March 29, 2018
2
April 15, 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
20386120006318 30 10386120006311 In Commercial Distribution Case
10386120006311 12 00386120006314 In Commercial Distribution Inner Carton
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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)

[?]
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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