DEVICE: E-PACK (10705031012776)

Device Identifier (DI) Information

E-PACK
8124E
In Commercial Distribution
8124E
ETHICON INC.
10705031012776
GS1

1
002144145 *Terms of Use
E-Pack Kits
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General/plastic surgical procedure kit, non-medicated, single-use A collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
GAQ Suture, nonabsorbable, steel, monofilament and multifilament, sterile
FTL Mesh, surgical, polymeric
LDF ELECTRODE, PACEMAKER, TEMPORARY
FZP CLIP, IMPLANTABLE
GAW SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
GAN SUTURE, ABSORBABLE, SYNTHETIC
GAM SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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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

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Storage and Handling
Storage Environment Temperature: less than 77 Degrees Fahrenheit
Storage Environment Temperature: less than 25 Degrees Celsius
Special Storage Condition, Specify: Away from moisture and direct heat
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

21f01e37-e993-435d-a200-f284677c6896
May 08, 2018
3
September 24, 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
No Package DIs found
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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

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