FDA.reportPublic FDA data

Insighter

Primary DI
06970831723321
Brand
Insighter
Company
Shenzhen Insighters Medical Technology Co., Ltd.
Model
i6-S
Published
2023-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970831723328PackageGS120In Commercial Distribution
26970831723325PackageGS15In Commercial Distribution
06970831723321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697083172332816970831723328
2697083172332526970831723325
06970831723321069708317233216970831723321

GMDN Terms#

Term, Definition table
TermDefinition
Video intubation laryngoscope bladeA rigid, blade-like component of a bladed video intubation laryngoscope intended to be inserted into the oral cavity 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 an electronic camera at its distal end to transmit anatomical images by a video system to a connected video intubation laryngoscope handle/monitor. This is a single-use device.

Regulatory Flags#

DUNS number
551096917
Device count
1
DM exempt
true
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
06970831723659InsightersVisible Left type 28Fr2026-04-14
06970831723666InsightersVisible Left type 32Fr2026-04-14
06970831723673InsightersVisible Left type 35Fr2026-04-14
06970831723680InsightersVisible Left type 37Fr2026-04-14
06970831723697InsightersVisible Left type 39Fr2026-04-14
06970831723703InsightersVisible Left type 41Fr2026-04-14
06970831723710InsightersVisible Right type 28Fr2026-04-14
06970831723727InsightersVisible Right type 32Fr2026-04-14
06970831723734InsightersVisible Right type 35Fr2026-04-14
06970831723741InsightersVisible Right type 37Fr2026-04-14
06970831723758InsightersVisible Right type 39Fr2026-04-14
06970831723765InsightersVisible Right type 41Fr2026-04-14
06970831723772InsightersVisible Left type B 28Fr2026-04-14
06970831723789InsightersVisible Left type B 32Fr2026-04-14
06970831723796InsightersVisible Left type B 35Fr2026-04-14
06970831723802InsightersVisible Left type B 37Fr2026-04-14
06970831723819InsightersVisible Left type B 39Fr2026-04-14
06970831723826InsightersVisible Left type B 41Fr2026-04-14
06970831723833InsightersVisible Right type B 28Fr2026-04-14
06970831723840InsightersVisible Right type B 32Fr2026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250407721749FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721756FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721770FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721787FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721794FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721831FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721862FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721879FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721916FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721923FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722036FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722043FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722050FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722067FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722388FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722395FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722401FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722418FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722425FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722432FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722456FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722463FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722470FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722487FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722494FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722500FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722517FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722524FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722531FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722548FENTEXFENTEX medical GmbHLRC2022-12-09