Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: MEDLINE FDA UDI
Generic Name: Arthroscopic shaver system blade, reprocessed FDA UDI
Device Name: AR-8400RBE COOLCUT RND BURR 8 FLT BL FDA UDI
Model / Reference: AR8400RBER FDA UDI
Description: AR-8400RBE COOLCUT RND BURR 8 FLT BL FDA UDI

Identifiers

Catalog Number: AR8400RBER FDA UDI
Primary DI / UDI-DI: 10888277389199 FDA UDI
510(k) Number: K113028 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Arthroscopic shaver system blade, reprocessed FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Arthroscopic shaver system blade, reprocessed

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

Similar devices

Also classified as Arthroscopic shaver system blade, reprocessed.

Arthrex — Provision · Class II
Conmed Linvatec — Provision · Class II
Arthrex — Provision · Class II
Sustainable Technologies — Provision · Class II
Reprocessed 3.5mm Full Radius Blade Plus — SURETEK MEDICAL · Class I
Smith and Nephew — Provision · Class II
Sustainable Technologies — Provision · Class II
Reprocessed 4.0mm Rad 60 Curved Blade, Rotatable — SURETEK MEDICAL · Class I

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medline Industries, Inc.

Sources (1)

FDA UDI 851af7fc-a57c-48d1-a80c-7ddc0441f3b1 36 fields · synced May 30, 2026