FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G141528202010
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
528-20201
Catalog number
528-20201
Device description
Hand table
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
G141528202010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Operating table orthopaedic extension, non-poweredA non-powered, orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder or spinal surgery, C- or O-arm use). It typically consists of height, length and angle adjustable supports or telescopic bars/plates (e.g., leg spar).

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
G1415189430Carnegie Surgical LLC518-943518-9432026-10-12
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
G141518123170Carnegie Surgical LLC518-12317518-123172026-10-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776439811MilleniumAvalign Technologies, Inc.GAD2026-10-28
B382SD907310080Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B382SD9141781200Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B382SD91417912190Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B8039018650ORTHOMEDORTHO-MED, INC.GAD2026-10-27
00190776437145MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437152MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437169MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776439781MilleniumAvalign Technologies, Inc.GAD2026-10-26
00190776436957MillenniumAvalign Technologies, Inc.GAD2026-10-23
00190776437015MillenniumAvalign Technologies, Inc.GAD2026-10-23
00190776437022MillenniumAvalign Technologies, Inc.GAD2026-10-23
00840277134011Innomed, Inc.INNOMED, INC.GAD2026-10-22
00190776435615MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435622MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435660MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435707MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435714MillenniumAvalign Technologies, Inc.GAD2026-10-21
00724995323998V. MuellerSTERIS Deutschland GmbHGAD2026-10-21
00840338612656Made-To-OrderTORNIER, INC.GAD2026-10-21
00190776435578MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19