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Ef1

FDA UDI

Class II (US FDA UDI)

by Medshape, Inc.

Identity

Trade Name
EF1 FDA UDI
Generic Name
External orthopaedic fixation system noninvasive component, single-use FDA UDI
Device Name
Half pin - 6 x 180mm with 25mm thread FDA UDI
Model / Reference
DNE-618025 FDA UDI
Description
Half pin - 6 x 180mm with 25mm thread FDA UDI

Identifiers

Primary DI / UDI-DI
00810028395961 FDA UDI
510(k) Number
K113106 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
External orthopaedic fixation system noninvasive component, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 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
MRI Safety
MR Unsafe FDA UDI

Category: External orthopaedic fixation system noninvasive component, single-use

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

Similar devices

Also classified as External orthopaedic fixation system noninvasive component, single-use.

Cleared under the same submission

K113106 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medshape, Inc.

Sources (1)

  • FDA UDI b3af715e-3252-4b41-852f-a61faf377c1d 34 fields · synced May 30, 2026