FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G1415189430
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
518-943
Catalog number
518-943
Device description
WEITLANER retractor 6 1/2" (16.5cm) 3x4 prongs, blunt
Published
2026-10-12
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
G1415189430PrimaryHIBCC0

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
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
G14155805420Carnegie Surgical LLC558-0542558-05422026-10-07

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Primary DI, Brand, Company table
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00190776433659MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776433741MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776434526MillenniumAvalign Technologies, Inc.GAD2026-10-07