← Back to catalogue

Made-To-Order

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Made-To-Order FDA UDI
Generic Name
Drilling power tool attachment, basic FDA UDI
Device Name
2-In-1 Drill/Reamer FDA UDI
Model / Reference
9027528 FDA UDI
Description
2-In-1 Drill/Reamer FDA UDI

Identifiers

Catalog Number
9027528 FDA UDI
Primary DI / UDI-DI
00846832097722 FDA UDI
FDA Product Code
HXX FDA UDI
HWE FDA UDI
GMDN Term
Drilling power tool attachment, basic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
878.4820 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: Bone-resection orthopaedic reamer, reusableDrilling power tool attachment, basic

Made-To-Order by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Drilling power tool attachment, basic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI 3f40a3bf-02ae-4214-ac72-18703e8cffdb 36 fields · synced May 30, 2026