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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
Suturing needle holder, reusable FDA UDI
Device Name
5 1/2 inch Castroviejo Needle Holder, Straight, Without Lock FDA UDI
Model / Reference
SD90565814 FDA UDI
Description
5 1/2 inch Castroviejo Needle Holder, Straight, Without Lock FDA UDI

Identifiers

Catalog Number
SD90565814 FDA UDI
Primary DI / UDI-DI
B382SD905658140 FDA UDI
FDA Product Code
FHQ FDA UDI
GMDN Term
Suturing needle holder, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4730 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: Suturing needle holder, reusable

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

Similar devices

Also classified as Suturing needle holder, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 8f8ce4d0-872e-4310-a2fe-23621aa0e32c 35 fields · synced May 30, 2026