FDA.report

INKA

Primary DI
09348811110183
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
35390.01
Catalog number
35390.01
Device description
KLEINSASSER style Operating Laryngoscope #1 infant size I.D. 11mm - 135mm
Published
2025-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CCWLaryngoscope, Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09348811110183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09348811110183093488111101839348811110183

GMDN Terms

TermDefinition
Laryngoscope handle, reusableThe hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide 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 reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
742109993
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
09348811023018INKA15341.152026-03-16
09348811023667INKA15423.112026-03-16
09348811103338INKA30420.142026-03-16
09348811111906INKA31252.032026-03-16
09348811112002INKA31255.082026-03-16
09348811150134INKA31270.16 RD2026-03-16
09348811151254INKA18261.142026-03-16
09348811103321INKA30420.082026-03-09
09348811150288INKA31241.16 RD2026-03-09
09348811150356INKA31252.12 RD2026-03-09
09348811000873INKA10236.3010236.302026-02-13
09348811000897INKA10237.1510237.152026-02-13
09348811000903INKA10237.1710237.172026-02-13
09348811000927INKA10237.1410237.142026-02-13
09348811000934INKA10237.2010237.202026-02-13
09348811000941INKA10237.2310237.232026-02-13
09348811000958INKA10237.2810237.282026-02-13
09348811000965INKA10237.3010237.302026-02-13
09348811000972INKA10237.3310237.332026-02-13
09348811000989INKA10237.3610237.362026-02-13

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