FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G14164746930
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
647-4693
Catalog number
647-4693
Device description
NEIVERT osteotome, left 8 1/2" (21.5 cm)
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
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G14164746930PrimaryHIBCC0

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) 249-2695info@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
G14150603080Carnegie Surgical LLC506-0308506-03082026-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432935MillenniumAvalign Technologies, Inc.HWM2026-09-30
00840329838676BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
00840329838683BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
G141647481020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
00190776432812MillenniumAvalign Technologies, Inc.HWM2026-09-29
00190776432713MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776432720MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776432737MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776431570MillenniumAvalign Technologies, Inc.HWM2026-09-22
00190776431037MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431044MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431051MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431020MillenniumAvalign Technologies, Inc.HWM2026-09-18
00190776429089MillenniumAvalign Technologies, Inc.HWM2026-09-04
00190776429096MillenniumAvalign Technologies, Inc.HWM2026-09-04
00810111227360OsteotomeTreace Medical Concepts, Inc.HWM2026-08-25
00190776425807MillenniumAvalign Technologies, Inc.HWM2026-08-17
10705034579887N/AMedos International SàrlHWM2026-08-14
10705034579894N/AMedos International SàrlHWM2026-08-14
00190776424459MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776424466MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776424473MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776422738MillenniumAvalign Technologies, Inc.HWM2026-08-03
07640221373663SCALASpineArt SAHWM2026-07-24
07640221373670SCALASpineArt SAHWM2026-07-24
00190776421861MillenniumAvalign Technologies, Inc.HWM2026-07-23
00190776400422MillenniumAvalign Technologies, Inc.HWM2026-07-17
00190776400439MillenniumAvalign Technologies, Inc.HWM2026-07-17
B756SBLDFLAT17010Shukla Blade S9BLADEShukla MedicalHWM2026-07-09
B756SBLDFLAT17020Shukla Blade S9BLADEShukla MedicalHWM2026-07-09