← Back to catalogue

Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Basic Pack 1 FDA UDI
Model / Reference
5701691 FDA UDI
Description
Basic Pack 1 FDA UDI

Identifiers

Catalog Number
5701691 FDA UDI
Primary DI / UDI-DI
10304040119584 FDA UDI
FDA Product Code
PPF FDA UDI
LRO FDA UDI
OJH FDA UDI
OGR FDA UDI
FDE FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
878.4370 FDA UDI
878.4800 FDA UDI
874.4420 FDA UDI
876.1500 FDA UDI
Commercial Distribution
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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

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
Henry Schein, Inc.

Sources (1)

  • FDA UDI a680cb6e-68b6-4f0f-82ff-09b0996d2a7e 34 fields · synced Jun 6, 2026