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Needle Holders

FDA UDI

Class I (US FDA UDI)

by Aurora Surgical, Llc

Identity

Trade Name
Needle Holders FDA UDI
Generic Name
Ophthalmic suture/needle passer FDA UDI
Device Name
Castroviejo Needle Holder, Standard Jaws 10mm, Curved Without Lock, (For 4.0-7.0 Suture) Stainless Steel FDA UDI
Model / Reference
AS11-043S FDA UDI
Description
Castroviejo Needle Holder, Standard Jaws 10mm, Curved Without Lock, (For 4.0-7.0 Suture) Stainless Steel FDA UDI

Identifiers

Catalog Number
AS11-043S FDA UDI
Primary DI / UDI-DI
08175700143042 FDA UDI
FDA Product Code
HNR FDA UDI
GMDN Term
Ophthalmic suture/needle passer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4350 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

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: Ophthalmic suture/needle passer

Needle Holders by Aurora Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic suture/needle passer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aurora Surgical, Llc

Sources (1)

  • FDA UDI 8fe04cfd-0308-4f8e-81d5-c84e498bf104 34 fields · synced May 30, 2026