DEVICE: Miltex® (00381780363821)

Device Identifier (DI) Information

Miltex®
62503
In Commercial Distribution

INTEGRA YORK PA, INC.
00381780363821
GS1

1
058088204 *Terms of Use
18" SZ 3-0 PLAIN GUT ABS C-3 CIR PREM 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
Catgut suture, plain A sterile, single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) 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 needle intended to be disposed of after single use. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GAL SUTURE, ABSORBABLE, NATURAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K020597 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

5b8c266c-8913-40e0-a27d-2cc6cc0e7987
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
10381780363828 12 00381780363821 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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