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Carnegie Surgical LLC

FDA UDI

Class I (US FDA UDI)

by Carnegie Surgical LLC

Identity

Trade Name
Carnegie Surgical LLC FDA UDI
Generic Name
General-purpose absorbent tip applicator/swab, reusable FDA UDI
Device Name
Duberstein Type Phenol Applicator, 0.6mm tip, 45° angle, 15.75cm length FDA UDI
Model / Reference
544-41200 FDA UDI
Description
Duberstein Type Phenol Applicator, 0.6mm tip, 45° angle, 15.75cm length FDA UDI

Identifiers

Catalog Number
544-41200 FDA UDI
Primary DI / UDI-DI
G141544412000 FDA UDI
FDA Product Code
GDG FDA UDI
GMDN Term
General-purpose absorbent tip applicator/swab, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General-purpose absorbent tip applicator/swab, reusable

Carnegie Surgical LLC by Carnegie Surgical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose absorbent tip applicator/swab, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carnegie Surgical LLC

Sources (1)

  • FDA UDI b7e2446c-25f7-495f-8be6-c355aec12c37 35 fields · synced May 30, 2026