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Henry Schein

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Suture removal kit FDA UDI
Device Name
ER Laceration Tray FDA UDI
Model / Reference
1125823 FDA UDI
Description
ER Laceration Tray FDA UDI

Identifiers

Catalog Number
1125823 FDA UDI
Primary DI / UDI-DI
10304040000004 FDA UDI
FDA Product Code
MCZ FDA UDI
GMDN Term
Suture removal kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

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
Sterilization Method
Ethylene Oxide FDA UDI

Category: Suture removal kit

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

Similar devices

Also classified as Suture removal kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI 70b6b54a-f40d-4f07-8860-9a4ffb908ce6 34 fields · synced Jun 8, 2026