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Tornier Simpliciti

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Tornier Simpliciti FDA UDI
Generic Name
Surgical mallet FDA UDI
Device Name
SLOTTED MALLET FDA UDI
Model / Reference
9722938 FDA UDI
Description
SLOTTED MALLET FDA UDI

Identifiers

Catalog Number
9722938 FDA UDI
Primary DI / UDI-DI
00846832016013 FDA UDI
FDA Product Code
HXL FDA UDI
GMDN Term
Surgical mallet FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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: Surgical mallet

Tornier Simpliciti by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical mallet.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI 51a13e64-e9cc-45c9-9c07-805717af5a32 35 fields · synced Jun 1, 2026