FDA.reportPublic FDA data

NOVALITE

Primary DI
00817499020910
Brand
NOVALITE
Company
NOVAMED-USA INC.
Model
14-600FO-01
Device description
"FO REUSABLE MEDIUM HANDLE WITH 2.7V XENON BULB - REQUIRING ""C-CELL"" BATTERY"
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
00817499020910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817499020910008174990209108174990209100817499020910

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.

Sterilization Methods#

Method table
Method

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817499020859NOVALITE18-600SMH2023-06-28
00817499020866NOVALITE18-600SPH2023-06-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00879123009340GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
00879123009357GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
08436031030112AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030211AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030310AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030419AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030518AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030617AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033908AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033922AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035018AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035117AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035216AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035902AirtraqPRODOL MEDITEC, SACCW2023-08-01
G14140464270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-05
G1414046400Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464290Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G1414046430Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464370Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464380Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G141404643850Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464390Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G1414046440Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464470Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464480Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464490Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466170Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03