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Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name
Surgical Direct FDA UDI
Generic Name
Screw extractor, reusable FDA UDI
Device Name
Extraction Bolt, 6mm, for 2.0mm Screws FDA UDI
Model / Reference
SD22597-5021 FDA UDI
Description
Extraction Bolt, 6mm, for 2.0mm Screws FDA UDI

Identifiers

Catalog Number
SD22597-5021 FDA UDI
Primary DI / UDI-DI
B382SD2259750210 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Screw 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

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: Screw extractor, reusable

Surgical Direct by Surgical Direct, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Screw extractor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI cee9f799-c5db-4de6-9b4a-b637281201a9 35 fields · synced Jun 6, 2026