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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
9027527 FDA UDI
Description
2-In-1 Drill/Reamer FDA UDI

Identifiers

Catalog Number
9027527 FDA UDI
Primary DI / UDI-DI
00846832097715 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

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI 334aa7d2-f7c7-43c9-a935-abd5f6b38946 36 fields · synced Jun 8, 2026