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Wave Calcaneal Fracture Plate

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Wave Calcaneal Fracture Plate FDA UDI
Generic Name
Drilling power tool attachment, basic FDA UDI
Device Name
DRILL FDA UDI
Model / Reference
ZPWSDR27 FDA UDI
Description
DRILL FDA UDI

Identifiers

Catalog Number
ZPWSDR27 FDA UDI
Primary DI / UDI-DI
00846832010431 FDA UDI
FDA Product Code
HWE FDA UDI
GMDN Term
Drilling power tool attachment, basic 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

Dimensions & Sizes

Size
Length — 160 Millimeter FDA UDI
Outer Diameter — 2.7 Millimeter FDA UDI

Category: Drilling power tool attachment, basic

Wave Calcaneal Fracture Plate 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 3c574e5e-f20b-4a65-ab8a-a765af357016 36 fields · synced May 31, 2026