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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
Glenoid orthopaedic reamer FDA UDI
Device Name
Ream and Run Reamer FDA UDI
Model / Reference
9027890 FDA UDI
Description
Ream and Run Reamer FDA UDI

Identifiers

Catalog Number
9027890 FDA UDI
Primary DI / UDI-DI
00840338602336 FDA UDI
FDA Product Code
HWE FDA UDI
GMDN Term
Glenoid orthopaedic reamer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
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: Glenoid orthopaedic reamer

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

Similar devices

Also classified as Glenoid orthopaedic reamer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI 16a6a26e-d8a4-4e7a-aed3-05cedb81d67d 36 fields · synced Jun 8, 2026