DEVICE: ETHI-PAK (10705031036727)

Device Identifier (DI) Information

ETHI-PAK
DS22
In Commercial Distribution
DS22
ETHICON INC.
10705031036727
GS1

12
002144145 *Terms of Use
Stainless Steel, Nonabsorbable Surgical Suture
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
15971 Metallic suture, monofilament
A single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
GAQ SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
GAT SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
GAP SUTURE, NONABSORBABLE, SILK
GAR Suture, nonabsorbable, synthetic, polyamide
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K931271 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

37c8834c-fa1d-49b7-ab95-bd481ef6131c
February 05, 2021
6
September 01, 2015
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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
20705031036724 12 10705031036727 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: 80705031036726 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(877)384-4266
xxx@xxx.xxx
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