FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G14157212010
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
572-1201
Catalog number
572-1201
Device description
Breast Spatula with handle 12-1/2” (31.5 cm), 1" x 7" (25mm x 18 cm) blade, serrated tip, semi mellable
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G14157212010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. 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
00190776433086MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433116MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433154MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433161MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776432959MillenniumAvalign Technologies, Inc.GAD2026-09-30
00190776432997MillenniumAvalign Technologies, Inc.GAD2026-09-30
G1415180500Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141518555120Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141528202010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572105820Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572106810Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572108210Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157211460Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157213040Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
00190776432874MillenniumAvalign Technologies, Inc.GAD2026-09-29
00190776432515MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432591MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432621MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432638MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432669MillenniumAvalign Technologies, Inc.GAD2026-09-28
00840329838829N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329838980N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839000N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839017N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266950Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24