← Back to catalogue

DynaNail

FDA UDI

Class I (US FDA UDI)

by Medshape, Inc.

Identity

Trade Name
DynaNail FDA UDI
Generic Name
Orthopaedic bone-fragment manipulator, single-use FDA UDI
Device Name
10mm Detachable Reamer Head FDA UDI
Model / Reference
2201-06-0100 FDA UDI
Description
10mm Detachable Reamer Head FDA UDI

Identifiers

Primary DI / UDI-DI
M97022010601000 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

DynaNail 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medshape, Inc.

Sources (1)

  • FDA UDI a6288630-31da-43e4-a7d1-3c12ac203d0b 33 fields · synced May 30, 2026