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Formula

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
Formula FDA UDI
Generic Name
Arthroscopic shaver system, electrically-powered FDA UDI
Device Name
[12-Flute, Left Helix Barrel Bur, Arthroscopic Shaver Blade, Do Not Resterilize, Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight] FDA UDI
Model / Reference
0375953012 FDA UDI
Description
[12-Flute, Left Helix Barrel Bur, Arthroscopic Shaver Blade, Do Not Resterilize, Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight] FDA UDI

Identifiers

Catalog Number
0375-953-012 FDA UDI
Primary DI / UDI-DI
07613327054903 FDA UDI
FDA Product Code
NBH FDA UDI
GMDN Term
Arthroscopic shaver system, electrically-powered FDA UDI

Classification

Device Class
Class I 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5.5 Millimeter FDA UDI
Length — 125.0 Millimeter FDA UDI

Category: Arthroscopic shaver system, electrically-powered

Formula by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic shaver system, electrically-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 3a227d57-1f14-473d-afe8-13b900c5df1f 36 fields · synced May 30, 2026