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Kirschner wire

FDA UDI

Class II (US FDA UDI)

by In2bones

Identity

Trade Name
Kirschner wire FDA UDI
Generic Name
Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name
K-WIRE NO STERILE DIAM 0.8 MM LENGTH 70 MM 1 SHARP TIP FDA UDI
Model / Reference
K10 NS070 FDA UDI
Description
K-WIRE NO STERILE DIAM 0.8 MM LENGTH 70 MM 1 SHARP TIP FDA UDI

Identifiers

Catalog Number
K10 NS070 FDA UDI
Primary DI / UDI-DI
43760225711567 FDA UDI
510(k) Number
K153204 FDA UDI
FDA Product Code
HTY FDA UDI
GMDN Term
Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Kirschner wire by In2bones — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153204 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
In2bones

Sources (1)

  • FDA UDI 39457c4a-901f-4960-b399-25b1eeb8eaaf 37 fields · synced Jun 6, 2026