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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
ENT surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
BARON suction tube 4 FR (1.3mm), with finger cutoff, working length 4“ (10 cm), with stylet FDA UDI
Model / Reference
506-3804 FDA UDI
Description
BARON suction tube 4 FR (1.3mm), with finger cutoff, working length 4“ (10 cm), with stylet FDA UDI

Identifiers

Catalog Number
506-3804 FDA UDI
Primary DI / UDI-DI
G14150638040 FDA UDI
FDA Product Code
KCB FDA UDI
GMDN Term
ENT surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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: ENT surgical procedure kit, non-medicated, 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 ENT surgical procedure kit, non-medicated, 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 d20b34f4-7848-4629-b813-79f60ada59d7 35 fields · synced Jun 8, 2026