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Ennovate C

FDA UDI

Class I (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name
ENNOVATE C FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Device Name
ENNOVATE C DRILL D2.8 F/FIXED/VAR.GUIDE FDA UDI
Model / Reference
SZ020R FDA UDI
Description
ENNOVATE C DRILL D2.8 F/FIXED/VAR.GUIDE FDA UDI

Identifiers

Catalog Number
SZ020R FDA UDI
Primary DI / UDI-DI
04046955624829 FDA UDI
FDA Product Code
HXB FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

Ennovate C by Aesculap, Inc. — Class I — 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
Aesculap, Inc.

Sources (1)

  • FDA UDI 36d2077f-55a7-4b6d-b7c1-038722eaf734 35 fields · synced May 31, 2026