E-PACK

Basic Information

• Brand Name: E-PACK
• Primary DI: 20705031242835
• Version / Model: 9904E
• Catalog Number: 9904E
• Company Name: ETHICON INC.
• Labeler DUNS: 002144145
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-27
• Public Version: 5
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 38cfe29b-3f2c-44a2-80de-4d3c842b3c26
• Distribution End Date: 2019-08-19

Device Description

E-Pack Procedure Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAM	SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID	General, Plastic Surgery	878.4493	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30705031242832	GS1	BOX	5	Not in Commercial Distribution	2019-08-19
Primary	20705031242835	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Away from moisture and direct heat