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Rossenwasser Dalk Trifacet Spatula, Chisel Shaped Tip, Stainless Steel

FDA UDI

Class I (US FDA UDI)

by Aurora Surgical, Llc

Identity

Trade Name
Rossenwasser Dalk Trifacet Spatula, Chisel Shaped Tip, Stainless Steel FDA UDI
Generic Name
Ophthalmic surgical probe, reusable FDA UDI
Device Name
Rossenwasser Dalk Trifacet Spatula, Chisel Shaped Tip, Stainless Steel FDA UDI
Model / Reference
AS8-209S FDA UDI
Description
Rossenwasser Dalk Trifacet Spatula, Chisel Shaped Tip, Stainless Steel FDA UDI

Identifiers

Catalog Number
AS8-209S FDA UDI
Primary DI / UDI-DI
08175700136884 FDA UDI
FDA Product Code
HND FDA UDI
GMDN Term
Ophthalmic surgical probe, reusable 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 surgical probe, reusable

Rossenwasser Dalk Trifacet Spatula, Chisel Shaped Tip, Stainless Steel by Aurora Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Ophthalmic surgical probe, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 2d279b4d-b43a-4453-8ac6-d65ac9ec4c61 34 fields · synced Jun 1, 2026