DEVICE: RELI® (00386120009896)

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Device Record History
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Device Identifier (DI) Information
RELI®
SK685-M
In Commercial Distribution
SK685-M
MYCO MEDICAL SUPPLIES INC.
00386120009896
GS1

1
879187821 *Terms of Use
REDISILK PRO BLK BR 2-0 YFS 18"
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Device Characteristics
MR Safe
No
Yes
Yes
Yes
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?
13910 Silk suture
A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
GAP Suture, Nonabsorbable, Silk
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K172149 000
No CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: Recommended to be stored below 86°F (30°C), away from moisture and direct heat.
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Clinically Relevant Size

[?]
Size Type Text
Length: 18 Inch
Device Size Text, specify: 2-0
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Device Record Status
5d7f39aa-6580-4df8-86ba-098ef03b647b
February 05, 2021
2
May 13, 2019
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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
20386120009890 30 10386120009893 In Commercial Distribution Case
10386120009893 12 00386120009896 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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