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Spine Instruments

FDA UDI

Class I (US FDA UDI)

by Medacta International

Identity

Trade Name
Spine Instruments FDA UDI
Generic Name
Bone tap, single-use FDA UDI
Device Name
3.2 Guide wire 305mm Drill bit Sterile FDA UDI
Model / Reference
03.65.10.0073 FDA UDI
Description
3.2 Guide wire 305mm Drill bit Sterile FDA UDI

Identifiers

Primary DI / UDI-DI
07630971282612 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Bone tap, 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

No

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: Bone tap, single-use

Spine Instruments by Medacta International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone tap, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medacta International

Sources (1)

  • FDA UDI 275ec6b2-ef90-4e2c-a51f-213046f5e596 33 fields · synced May 30, 2026