FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G14140466370
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
404-6637
Catalog number
404-6637
Device description
MACINTOSH Laryngoscope blade fig 3, conventional with LED and small plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (111 mm) (pack of 10)
Published
2023-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G14140466371PackageHIBCC10In Commercial Distribution
G14140466372PackageHIBCC10In Commercial Distribution
G14140466370PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid intubation laryngoscope, single-useA hand-held disposable device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(609) 249-2696info@carnegiesurgical.com

Regulatory Flags#

DUNS number
017636482
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G141511062120Carnegie Surgical LLC511-06212511-062122025-09-20
G1415105458200Carnegie Surgical LLC510-545820510-5458202025-02-19
G141546076750Carnegie Surgical LLC546-07675546-076752025-02-19
G14167216220Carnegie Surgical LLC672-1622672-16222025-02-19
G141509430160Carnegie Surgical LLC509-43016509-430162025-02-03
G141514231000Carnegie Surgical LLC514-23100514-231002025-02-03
G1415181360Carnegie Surgical LLC518-136518-1362025-02-03
G141546380150Carnegie Surgical LLC546-38015546-380152025-02-03
G14155029060Carnegie Surgical LLC550-2906550-29062025-02-03
G141644139010Carnegie Surgical LLC644-13901644-139012025-02-03
G141549052210Carnegie Surgical LLC549-05221549-052212025-01-17
G141509462210Carnegie Surgical LLC509-46221509-462212024-09-03
G14144752210Carnegie Surgical LLC447-5221447-52212024-09-02
G14144752230Carnegie Surgical LLC447-5223447-52232024-09-02
G14144752250Carnegie Surgical LLC447-5225447-52252024-09-02
G14144752290Carnegie Surgical LLC447-5229447-52292024-09-02
G141502319120Carnegie Surgical LLC502-31912502-319122024-09-02
G141502583200Carnegie Surgical LLC502-58320502-583202024-09-02
G14150621020Carnegie Surgical LLC506-2102506-21022024-09-02
G14150637050Carnegie Surgical LLC506-3705506-37052024-09-02

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