FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G14150637050
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
506-3705
Catalog number
506-3705
Device description
BARON (SCHUKNECHT) suction tube 5 FR (1.7mm), with finger cutoff, working length 3“ (7.5cm), 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
G14150637050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. 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
G14150637070Carnegie Surgical LLC506-3707506-37072024-09-02

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B382SD911430150Surgical DirectSurgical Direct, Inc.KCB2025-12-02
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B382SD911500010Surgical DirectSurgical Direct, Inc.KCB2025-11-05