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Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name
Arthrex® FDA UDI
Generic Name
Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Device Name
IBAL TKA,BEARING IMP,PS,SZ 2,18MM FDA UDI
Model / Reference
AR-513-BC18 FDA UDI
Description
IBAL TKA,BEARING IMP,PS,SZ 2,18MM FDA UDI

Identifiers

Catalog Number
AR-513-BC18 FDA UDI
Primary DI / UDI-DI
00888867107113 FDA UDI
FDA Product Code
KRR FDA UDI
MBH FDA UDI
HSX FDA UDI
GMDN Term
Surgical implant/trial-implant/sizer holder, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3540 FDA UDI
888.3565 FDA UDI
888.3520 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Surgical implant/trial-implant/sizer holder, reusable

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

Similar devices

Also classified as Surgical implant/trial-implant/sizer holder, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arthrex, Inc.

Sources (1)

  • FDA UDI 9a0e18f8-b3ba-4332-869e-9077bf6c64aa 35 fields · synced May 31, 2026