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Hls Noetos Revision

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
HLS NOETOS REVISION FDA UDI
Generic Name
Uncoated knee femur prosthesis, metallic FDA UDI
Model / Reference
GDF554 FDA UDI

Identifiers

Primary DI / UDI-DI
03700386911873 FDA UDI
510(k) Number
K032079 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Uncoated knee femur prosthesis, metallic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Hls Noetos Revision by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K032079 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI dd0d7d48-f0d3-4086-ba0a-2d77e9803422 36 fields · synced May 31, 2026