← Back to catalogue

Henry Schein

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Dental material cartridge-plunging applicator, two-component, manual FDA UDI
Device Name
Schein HP Dispensing Gun FDA UDI
Model / Reference
1126775 FDA UDI
Description
Schein HP Dispensing Gun FDA UDI

Identifiers

Catalog Number
1126775 FDA UDI
Primary DI / UDI-DI
00304040114445 FDA UDI
FDA Product Code
EID FDA UDI
GMDN Term
Dental material cartridge-plunging applicator, two-component, manual FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental material cartridge-plunging applicator, two-component, manual

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

Similar devices

Also classified as Dental material cartridge-plunging applicator, two-component, manual.

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 27abed98-222f-4509-aa6f-b30ab9454c65 34 fields · synced Jun 8, 2026