DEVICE: Miltex® (00381780363890)

Device Identifier (DI) Information

Miltex®
62510
In Commercial Distribution

INTEGRA YORK PA, INC.
00381780363890
GS1

1
058088204 *Terms of Use
18" SZ3-0 SLK BLK NON-ABS C-9 NEEDLE CIR REV CUT
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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
Silk suture, sterile A sterile, 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 needle. 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.
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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 [?]
K020901 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
Device Size Text, specify: 18" Size 3-0
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Device Record Status

cddda64a-abd9-423b-ac97-042caa325985
July 06, 2018
3
January 05, 2017
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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
10381780363897 12 00381780363890 In Commercial Distribution BOX
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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

[?]
+1(800)654-2873
custsvcnj@integralife.com
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