FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G14150603080
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
506-0308
Catalog number
506-0308
Device description
YANKAUER suction tube 11-1/4“ (28.5cm), with special central bore Ø 2,0mm, with Fiber optic attachment, complete with tube olive
Published
2026-09-30
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
G14150603080PrimaryHIBCC0

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) 249-2695info@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
G141509455170Carnegie Surgical LLC509-45517509-455172026-09-30
G141510443190Carnegie Surgical LLC510-44319510-443192026-09-30
G141510586170Carnegie Surgical LLC510-58617510-586172026-09-30
G141511368200Carnegie Surgical LLC511-36820511-368202026-09-30
G141511368300Carnegie Surgical LLC511-36830511-368302026-09-30
G14151423610Carnegie Surgical LLC514-236514-2362026-09-30
G1415180500Carnegie Surgical LLC518-050518-0502026-09-30
G141518555120Carnegie Surgical LLC518-55512518-555122026-09-30
G141520422030Carnegie Surgical LLC520-42203520-422032026-09-30
G141520422040Carnegie Surgical LLC520-42204520-422042026-09-30
G141520426040Carnegie Surgical LLC520-42604520-426042026-09-30
G141521149260Carnegie Surgical LLC521-14926521-149262026-09-30
G1415241110Carnegie Surgical LLC524-111524-1112026-09-30
G14152810910Carnegie Surgical LLC528-1091528-10912026-09-30
G141528202010Carnegie Surgical LLC528-20201528-202012026-09-30
G14154212860Carnegie Surgical LLC542-1286542-12862026-09-30
G141546073500Carnegie Surgical LLC546-07350546-073502026-09-30
G14154661010Carnegie Surgical LLC546-6101546-61012026-09-30
G14154661030Carnegie Surgical LLC546-6103546-61032026-09-30
G141547374150Carnegie Surgical LLC547-37415547-374152026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD921329100Surgical DirectSurgical Direct, Inc.KCB2026-09-30
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
B382SD9114511500Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511680Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911454070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860310Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860320Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860330Surgical DirectSurgical Direct, Inc.KCB2026-02-05