FDA.reportPublic FDA data

NOVALITE

Primary DI
00817499020866
Brand
NOVALITE
Company
NOVAMED-USA INC.
Model
18-600SPH
Device description
SINGLE USE STD PENLIGHT LARYNGOSCOPE HANDLE - (2) 1.5V ALKALINE BATTERIES PRELOADED
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
10817499020863PackageGS110In Commercial Distribution
00817499020866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081749902086310817499020863
00817499020866008174990208668174990208660817499020866

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope handle, single-useA clean, non-sterile, hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) designed to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains batteries/light-emitting cells to provide the energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. This is a single-use device; the batteries/light-emitting cells are intended to be removed for reuse before the device is discarded.

Contacts#

Phone, Email table
PhoneEmail
914-789-2100info@novamed-usa.com

Regulatory Flags#

DUNS number
831531426
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817499020859NOVALITE18-600SMH2023-06-28
00817499020873NOVALITE18-600SSH2023-06-28
00817499020453NOVATEMP11-CA-400-122023-06-28
00817499020460NOVATEMP11-CA-400-202023-06-28
00817499020477NOVATEMP11-CA-401-122023-06-28
00817499020484NOVATEMP11-CA-401-202023-06-28
00817499020491NOVATEMP11-CA-402-102023-06-28
00817499020507NOVATEMP11-CA-402-122023-06-28
00817499020514NOVATEMP11-CA-402-202023-06-28
00817499020521NOVATEMP11-CA-403-122023-06-28
00817499020538NOVATEMP11-CA-404-122023-06-28
00817499020545NOVATEMP11-CA-404-202023-06-28
00817499020552NOVATEMP11-CA-405-122023-06-28
00817499020569NOVATEMP11-CA-407-042023-06-28
00817499020576NOVATEMP11-CA-407-122023-06-28
10817499020856NOVALITE18-600SMH2023-06-28
10817499020863NOVALITE18-600SPH2023-06-28
10817499020870NOVALITE18-600SSH2023-06-28
00817499020880NOVALITE14-600S-012023-06-28
00817499020897NOVALITE14-600S-022023-06-28

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