FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G141554330180
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
554-33018
Catalog number
554-33018
Device description
ST. MARKS Retractor, angled handle, with lip angled 15°, blade 11" (280mm), Overall length 40cm, with Fiber Optic Attachment.
Published
2023-03-26
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
FDGRetractor, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G141554330180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
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
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
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
G14150637070Carnegie Surgical LLC506-3707506-37072024-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812432023218Lumitex Surgical Tube IlluminatorLumitex, Inc.FDG2026-03-23
G4255721131S0My MedicalMy Medical Store LLCFDG2026-02-27
00812432023133Light Cable, Vaginal RetractorLumitex, Inc.FDG2026-02-11
00812432023164Medtronic 4mm Universal Reusable Light CableLUMITEX, INC.FDG2026-01-07
00812432023171Medtronic 4mm ACMI Cable AdapterLUMITEX, INC.FDG2026-01-07
00812432023188Medtronic 4mm WOLF Cable AdapterLUMITEX, INC.FDG2026-01-07
00812432023195Medtronic 4mm OLYMPUS Cable AdapterLUMITEX, INC.FDG2026-01-07
00812432023201Medtronic 4mm STORZ Cable AdapterLUMITEX, INC.FDG2026-01-07
03662663273350Timberline Lateral Fusion SystemHighridge Medical, LLCFDG2025-12-18
00812432023072L&K Biomed BluEX Surgical IlluminatorLUMITEX, INC.FDG2025-12-11
00812432023096Lumitex Surgical IlluminatorLumitex, Inc.FDG2025-10-23
008124320230654WEB Medical OA51S Surgical IlluminatorLUMITEX, INC.FDG2025-04-08
00840183529512BR Surgical, LLCBR Surgical, LLCFDG2025-02-12
00812432023041Precision Spine TLIF Bifurcated Surgical IlluminatorLUMITEX, INC.FDG2024-10-25
00812432023058Lattus Spine Surgical IlluminatorLUMITEX, INC.FDG2024-06-21
00840183514235BR Surgical, LLCBR Surgical, LLCFDG2024-03-11
G4251106670My MedicalMy Medical Store LLCFDG2024-03-07
G425110679LS0My MedicalMy Medical Store LLCFDG2024-03-07
00840183525620BR Surgical, LLCBR Surgical, LLCFDG2024-03-04
10888515319360BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319414BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319421BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319438BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
00888515319455BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
00888515319462BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319476BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-20
00190376508085ATEC Light Cable SystemALPHATEC SPINE, INC.FDG2024-02-02
00190376508092ATEC Light Cable SystemALPHATEC SPINE, INC.FDG2024-02-02
00840183513887BR Surgical, LLCBR Surgical, LLCFDG2024-02-01
00840306811586Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FDG2024-01-30