AccessGUDID - DEVICE: E-PACK (10705031012363)

GUDID

Device Identifier (DI) Information

Brand Name: E-PACK
Version or Model: 8045E
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8045E
Company Name: ETHICON INC.

Primary DI Number: 10705031012363
Issuing Agency: GS1
Commercial Distribution End Date: July 08, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 002144145 *Terms of Use

Device Description: E-Pack Procedure Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33961	General surgical procedure kit, non-medicated, single-use	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b62b808-9061-4885-ba15-aaf4e3cc2e21
Public Version Date: June 17, 2022
Public Version Number: 6
DI Record Publish Date: September 20, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20705031012360	5	10705031012363	2019-07-08	Not in Commercial Distribution	BX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)384-4266
Email: xxx@xxx.xxx

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