← Back to catalogue

E-Pack

FDA UDI

Class II (US FDA UDI)

by Ethicon Inc.

Identity

Trade Name
E-PACK FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
E-Pack Procedure Kit FDA UDI
Model / Reference
9937E FDA UDI
Description
E-Pack Procedure Kit FDA UDI

Identifiers

Catalog Number
9937E FDA UDI
Primary DI / UDI-DI
20705031245447 FDA UDI
FDA Product Code
GAN FDA UDI
FZP FDA UDI
GAM FDA UDI
FTL FDA UDI
GAW FDA UDI
GAQ FDA UDI
LDF FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4830 FDA UDI
878.4300 FDA UDI
878.4493 FDA UDI
878.3300 FDA UDI
878.5010 FDA UDI
878.4495 FDA UDI
870.3680 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

E-Pack by Ethicon Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ethicon Inc.

Sources (1)

  • FDA UDI d18f8f3c-d9b7-4509-88ec-4900a5c708b8 37 fields · synced Jun 8, 2026