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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
CORE BIOPSY TRAY FDA UDI
Model / Reference
SPEC0083B FDA UDI
Description
CORE BIOPSY TRAY FDA UDI

Identifiers

Catalog Number
SPEC0083B FDA UDI
Primary DI / UDI-DI
10193489196634 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

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI e512d0a6-fdc5-48b9-b158-eff182f628cb 35 fields · synced May 31, 2026