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Shoulder iD

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Shoulder iD FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Device Name
BLUEPRINT Primary Reversed Bone Model FDA UDI
Model / Reference
MWJ015 FDA UDI
Description
BLUEPRINT Primary Reversed Bone Model FDA UDI

Identifiers

Catalog Number
MWJ015 FDA UDI
Primary DI / UDI-DI
03700434023732 FDA UDI
FDA Product Code
KWS FDA UDI
QHE FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

Shoulder iD by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI e4d9a9dc-4752-43ca-a94a-44a7f7d92a51 35 fields · synced Jun 1, 2026