FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G1412001820
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
200-182
Catalog number
200-182
Device description
Neivert Osteotome -Straight, Single Guarded 20cm/8in
Published
2024-08-16
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
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G1412001820PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810143904666SURGIPROSSurgipros, LLCHWM2026-06-01
00810143904673SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907261SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907278SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907308SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907315SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930008SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930015SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930022SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930039SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930046SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930053SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930060SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930077SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930084SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930091SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930107SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930114SURGIPROSSurgipros, LLCHWM2026-06-01
09348811099624INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811110442INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811111289INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
10381780503316Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503323Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503330Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503347Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503354Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10603295080770NADEPUY (IRELAND)HWM2018-09-24
10603295080787NADEPUY (IRELAND)HWM2018-09-24
10603295080794NADEPUY (IRELAND)HWM2018-09-24
10603295083160SIGMADEPUY (IRELAND)HWM2018-09-24