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Ef1

FDA UDI

Class I (US FDA UDI)

by Medshape, Inc.

Identity

Trade Name
EF1 FDA UDI
Generic Name
Orthopaedic bone-fragment manipulator, single-use FDA UDI
Device Name
Steel T Handle FDA UDI
Model / Reference
DNE-9000-TH-ST FDA UDI
Description
Steel T Handle FDA UDI

Identifiers

Primary DI / UDI-DI
00810028397750 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic bone-fragment manipulator, 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

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: Orthopaedic bone-fragment manipulator, single-use

Ef1 by Medshape, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone-fragment manipulator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medshape, Inc.

Sources (1)

  • FDA UDI d8f75fd0-4c17-4169-8c26-8d2d73e3841b 33 fields · synced May 30, 2026