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XtraFix®

FDA UDI

Class I (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
XtraFix® FDA UDI
Generic Name
Fluted surgical drill bit, single-use, non-sterile FDA UDI
Model / Reference
00-5210-090-03 FDA UDI

Identifiers

Catalog Number
00-5210-090-03 FDA UDI
Primary DI / UDI-DI
00889024081390 FDA UDI
FDA Product Code
HXX FDA UDI
GMDN Term
Fluted surgical drill bit, single-use, non-sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
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

Category: Fluted surgical drill bit, single-use, non-sterile

XtraFix® by Zimmer, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluted surgical drill bit, single-use, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zimmer, Inc.

Sources (1)

  • FDA UDI 2e6bf21b-64fa-4750-b359-6e7f7712589d 34 fields · synced May 30, 2026