FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G141518123170
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
518-12317
Catalog number
518-12317
Device description
Lerut FISCH Retractor, 3 x 3 prongs, articulated, semi-sharp, length (17 cm)
Published
2026-10-07
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
G141518123170PrimaryHIBCC0

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) 249-2695info@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
G141548140010Carnegie Surgical LLC548-14001548-140012026-10-08
G141502302260Carnegie Surgical LLC502-30226502-302262026-10-07
G14150603010Carnegie Surgical LLC506-0301506-03012026-10-07
G14150603230Carnegie Surgical LLC506-0323506-03232026-10-07
G14150609010Carnegie Surgical LLC506-0901506-09012026-10-07
G141510457190Carnegie Surgical LLC510-45719510-457192026-10-07
G1415140730Carnegie Surgical LLC514-073514-0732026-10-07
G1415141510Carnegie Surgical LLC514-151514-1512026-10-07
G141514271180Carnegie Surgical LLC514-27118514-271182026-10-07
G141518861000Carnegie Surgical LLC518-86100518-861002026-10-07
G141526051160Carnegie Surgical LLC526-05116526-051162026-10-07
G141530254210Carnegie Surgical LLC530-25421530-254212026-10-07
G141548140020Carnegie Surgical LLC548-14002548-140022026-10-07
G141548807040Carnegie Surgical LLC548-80704548-807042026-10-07
G141548807060Carnegie Surgical LLC548-80706548-807062026-10-07
G141549012180Carnegie Surgical LLC549-01218549-012182026-10-07
G141549966080Carnegie Surgical LLC549-96608549-966082026-10-07
G14155805410Carnegie Surgical LLC558-0541558-05412026-10-07
G14155805420Carnegie Surgical LLC558-0542558-05422026-10-07
G14156020340Carnegie Surgical LLC560-2034560-20342026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433826MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776433833MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776433871MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776434014MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776436285MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776433628MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776433642MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776433659MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776433741MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776434526MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776436179MillenniumAvalign Technologies, Inc.GAD2026-10-07
G141518861000Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
G141572107210Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
G14157211050Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
G141572114910Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
00190776433543MillenniumAvalign Technologies, Inc.GAD2026-10-06
00841536148497ThompsonThompson Surgical Instruments, Inc.GAD2026-10-06
B7687419600Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.GAD2026-10-06
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