FDA.report

Innomed, Inc.

Primary DI
00840277126016
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
8011-01
Catalog number
8011-0
Device description
Standard Short Light Wand Only (.187 x 3)
Published
2020-06-30
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
EQHSource, Carrier, Fiberoptic Light
FCWLight Source, Fiberoptic, Routine
HXBProbe

Product Code Classifications

CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2
HXBProbeOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840277126016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277126016008402771260168402771260160840277126016

GMDN Terms

TermDefinition
Light source adaptorA small connecting device designed to permit the connection of the devices that together deliver light to a work field from a light source. This device is used to connect together products of dissimilar manufacture and dimensions, e.g., a fibreoptic light cable of one manufacture to the light source of another. It may also be used at the instrument end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
878427491
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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