FDA.reportPublic FDA data

Insighter

Primary DI
16970831723274
Brand
Insighter
Company
Shenzhen Insighters Medical Technology Co., Ltd.
Model
SS
Published
2023-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
16970831723274PackageGS120In Commercial Distribution
26970831723271PackageGS15In Commercial Distribution
06970831723277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697083172327416970831723274
2697083172327126970831723271
06970831723277069708317232776970831723277

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551096917
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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08904461055697OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
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