FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G1415530254210
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
530-25421
Catalog number
530-25421
Device description
SACHS Dissector sharp, 3mm, 8-1/2" (21cm)
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
GDIDissector, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G1415530254210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, 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
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

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Primary DI, Brand, Company table
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00190776408626MillenniumAvalign Technologies, Inc.GDI2026-08-03
B382SD914709040Surgical DirectSurgical Direct, Inc.GDI2026-07-29
00810068850765Biocore9 Acetabular Bearing SystemBiocore9, LLCGDI2026-06-26
07898789390121ENDOFOREHEAD DISSECTOR 5MM ANGLEDTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-06-09
07898789390138ENDOFOREHEAD DISSECTOR WITH SUCTION STRAIGHT 30CMTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-06-09
07898789390039GRAIVIER MID-FACE DISSECTOR LEFTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390046GRAIVIER MID-FACE DISSECTOR RIGHTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
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