FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G14150638030
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
506-3803
Catalog number
506-3803
Device description
BARON suction tube 3 FR (1mm), with finger cutoff, working length 4“ (10 cm), with stylet
Published
2024-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCBTube, Tonsil Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCBTube, Tonsil SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G14150638030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(609) 249-2697info@carnegiesurgical.com

Regulatory Flags#

DUNS number
017636482
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G141511062120Carnegie Surgical LLC511-06212511-062122025-09-20
G1415105458200Carnegie Surgical LLC510-545820510-5458202025-02-19
G141546076750Carnegie Surgical LLC546-07675546-076752025-02-19
G14167216220Carnegie Surgical LLC672-1622672-16222025-02-19
G141509430160Carnegie Surgical LLC509-43016509-430162025-02-03
G141514231000Carnegie Surgical LLC514-23100514-231002025-02-03
G1415181360Carnegie Surgical LLC518-136518-1362025-02-03
G141546380150Carnegie Surgical LLC546-38015546-380152025-02-03
G14155029060Carnegie Surgical LLC550-2906550-29062025-02-03
G141644139010Carnegie Surgical LLC644-13901644-139012025-02-03
G141549052210Carnegie Surgical LLC549-05221549-052212025-01-17
G141509462210Carnegie Surgical LLC509-46221509-462212024-09-03
G14144752210Carnegie Surgical LLC447-5221447-52212024-09-02
G14144752230Carnegie Surgical LLC447-5223447-52232024-09-02
G14144752250Carnegie Surgical LLC447-5225447-52252024-09-02
G14144752290Carnegie Surgical LLC447-5229447-52292024-09-02
G141502319120Carnegie Surgical LLC502-31912502-319122024-09-02
G141502583200Carnegie Surgical LLC502-58320502-583202024-09-02
G14150621020Carnegie Surgical LLC506-2102506-21022024-09-02
G14150637050Carnegie Surgical LLC506-3705506-37052024-09-02

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Primary DI, Brand, Company table
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B382SD49301300Surgical DirectSurgical Direct, Inc.KCB2026-02-05
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B382SD911454070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
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B382SD911430150Surgical DirectSurgical Direct, Inc.KCB2025-12-02
B382SD471400820Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114311000Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114312000Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114511830Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD911451185A0Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD911500010Surgical DirectSurgical Direct, Inc.KCB2025-11-05