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Reform POCT System

FDA UDI

Class I (US FDA UDI)

by Precision Spine, Inc.

Identity

Trade Name
Reform POCT System FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Ø4.5mm Bone Tap FDA UDI
Model / Reference
55-IN-2045 FDA UDI
Description
Ø4.5mm Bone Tap FDA UDI

Identifiers

Catalog Number
55-IN-2045 FDA UDI
Primary DI / UDI-DI
00840019926393 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable 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

No

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 surgical procedure kit, non-medicated, reusable

Reform POCT System by Precision Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Precision Spine, Inc.

Sources (1)

  • FDA UDI 3208b053-2855-4926-bc53-96192fc050a0 34 fields · synced May 31, 2026