FDA.report

N/A

Primary DI
04961333242597
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
92206/15
Device description
15 FT SVGA HD-15 MALE TO MALE CABLE
Published
2018-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications

CodeDeviceSpecialtyClass
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04961333242597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04961333242597049613332425974961333242597

GMDN Terms

TermDefinition
Endoscopic video image processing unitA mains electricity (AC-powered) device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Device Sizes

TypeValueUnit
Length15Feet

Sterilization Methods

Method

Regulatory Flags

DUNS number
083211284
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false

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04961333248018ENDOPRO NETWORK CAPTURE WORKSTATIONKBM683452020-03-26
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