FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G14150603010
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
506-0301
Catalog number
506-0301
Device description
YANKAUER suction tube 11-1/4“ (28.5cm), with special central bore Ø 4.8mm for tonsillectomy, with tube olive
Published
2026-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
G14150603010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(609) 249-2695info@carnegiesurgical.com

Regulatory Flags#

DUNS number
017636482
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G141548140010Carnegie Surgical LLC548-14001548-140012026-10-08
G141502302260Carnegie Surgical LLC502-30226502-302262026-10-07
G14150603230Carnegie Surgical LLC506-0323506-03232026-10-07
G14150609010Carnegie Surgical LLC506-0901506-09012026-10-07
G141510457190Carnegie Surgical LLC510-45719510-457192026-10-07
G1415140730Carnegie Surgical LLC514-073514-0732026-10-07
G1415141510Carnegie Surgical LLC514-151514-1512026-10-07
G141514271180Carnegie Surgical LLC514-27118514-271182026-10-07
G141518123170Carnegie Surgical LLC518-12317518-123172026-10-07
G141518861000Carnegie Surgical LLC518-86100518-861002026-10-07
G141526051160Carnegie Surgical LLC526-05116526-051162026-10-07
G141530254210Carnegie Surgical LLC530-25421530-254212026-10-07
G141548140020Carnegie Surgical LLC548-14002548-140022026-10-07
G141548807040Carnegie Surgical LLC548-80704548-807042026-10-07
G141548807060Carnegie Surgical LLC548-80706548-807062026-10-07
G141549012180Carnegie Surgical LLC549-01218549-012182026-10-07
G141549966080Carnegie Surgical LLC549-96608549-966082026-10-07
G14155805410Carnegie Surgical LLC558-0541558-05412026-10-07
G14155805420Carnegie Surgical LLC558-0542558-05422026-10-07
G14156020340Carnegie Surgical LLC560-2034560-20342026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436452MilleniumAvalign Technologies, Inc.KCB2026-10-08
B382SD911160330Surgical DirectSurgical Direct, Inc.KCB2026-10-08
G14150603230Carnegie Surgical LLCCarnegie Surgical LLCKCB2026-10-07
G14150609010Carnegie Surgical LLCCarnegie Surgical LLCKCB2026-10-07
G14156020340Carnegie Surgical LLCCarnegie Surgical LLCKCB2026-10-07
B382SD921329100Surgical DirectSurgical Direct, Inc.KCB2026-09-30
G14150603080Carnegie Surgical LLCCarnegie Surgical LLCKCB2026-09-30
00190776423919MillenniumAvalign Technologies, Inc.KCB2026-08-26
00190776426460MillenniumAvalign Technologies, Inc.KCB2026-08-18
00190776426477MillenniumAvalign Technologies, Inc.KCB2026-08-18
00190776408831MillenniumAvalign Technologies, Inc.KCB2026-08-03
B382SD9114061030Surgical DirectSurgical Direct, Inc.KCB2026-07-23
00840183531690BR Surgical, LLCBR Surgical, LLCKCB2026-07-16
00840183532635BR Surgical, LLCBR Surgical, LLCKCB2026-07-16
B382SD48301400Surgical DirectSurgical Direct, Inc.KCB2026-03-09
B382SD911451080Surgical DirectSurgical Direct, Inc.KCB2026-03-02
B382SD6770650Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9194441080Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD920223100Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9204111140Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9227771100Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD49301300Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD4930130450Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD61042070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD6786020Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911430081A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD91143014A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911431107A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511180Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511490Surgical DirectSurgical Direct, Inc.KCB2026-02-05