← Back to catalogue

Medline

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
MEDLINE FDA UDI
Generic Name
General surgical procedure kit, medicated FDA UDI
Device Name
GK HEAD FRAME SET-UP & REMOVAL PACK FDA UDI
Model / Reference
MNS10050B FDA UDI
Description
GK HEAD FRAME SET-UP & REMOVAL PACK FDA UDI

Identifiers

Catalog Number
MNS10050B FDA UDI
Primary DI / UDI-DI
10653160386292 FDA UDI
FDA Product Code
LRP FDA UDI
GMDN Term
General surgical procedure kit, medicated 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

Yes

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

Category: General surgical procedure kit, medicated

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

Similar devices

Also classified as General surgical procedure kit, medicated.

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
Medline Industries, Inc.

Sources (1)

  • FDA UDI 8f069879-7db5-4975-9b09-2a59026ad926 35 fields · synced May 30, 2026