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Affiniti

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Affiniti FDA UDI
Generic Name
Drilling power tool attachment, basic FDA UDI
Device Name
GLENOID CENTER DRILL BIT FDA UDI
Model / Reference
9000284 FDA UDI
Description
GLENOID CENTER DRILL BIT FDA UDI

Identifiers

Catalog Number
9000284 FDA UDI
Primary DI / UDI-DI
00846832021666 FDA UDI
FDA Product Code
HWE FDA UDI
GMDN Term
Drilling power tool attachment, basic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

The Affiniti GLENOID CENTER DRILL BIT is a high-performance drilling power tool attachment designed for general and plastic surgery procedures. Made of durable stainless steel and synthetic materials, it features an extended body length and integral design with various attachments, making it ideal for micro and macro drillings. The device has been rigorously tested to ensure its safety and effectiveness, and has received OTC clearance from the FDA.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI ab02a8a6-671e-4021-88a4-55893f381e33 37 fields · synced Jul 30, 2026