← Back to catalogue

Screwdriver

FDA UDI

Class I (US FDA UDI)

by Parcus Medical Llc

Identity

Trade Name
SCREWDRIVER FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
4.5 REUSEABLE DRIVER KNOTLESS FDA UDI
Model / Reference
10487 FDA UDI
Description
4.5 REUSEABLE DRIVER KNOTLESS FDA UDI

Identifiers

Primary DI / UDI-DI
00816342021418 FDA UDI
FDA Product Code
HXX FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, 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

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

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Screwdriver by Parcus Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

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
Parcus Medical Llc

Sources (1)

  • FDA UDI e6413acd-a3fc-41ce-a6c5-cfc31933b21d 33 fields · synced May 30, 2026