FDA.report

NA

Primary DI
10886705026258
Brand
NA
Company
Medos International Sàrl
Model
242400
Catalog number
242400
Device description
TCK1 HD Camera Head, C-Mount
Published
2016-01-30
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

Contact Domains

Product Codes

CodeName
FWFCAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO

Product Code Classifications

CodeDeviceSpecialtyClass
FWFCamera, Television, Endoscopic, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10886705026258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088670502625810886705026258

GMDN Terms

TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-14 Degrees Fahrenheit158 Degrees Fahrenheit
Handling Environment Temperature-10 Degrees Celsius70 Degrees Celsius
Special Storage Condition, Specify00Waste Electrical and Electronic Equipment
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-14 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method
Ethylene Oxide;Hydrogen Peroxide

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
482661753
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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10886705022724RIGIDLOOP2320222320222015-09-01
10886705022731RIGIDLOOP2320232320232015-09-01
10886705022755RIGIDLOOP2320282320282015-09-01
10886705022830RIGIDLOOP2320372320372015-09-01
10886705024070RIGIDLOOP2180342180342015-09-01
10886705024094RIGIDLOOP2324472324472015-09-01
10886705024100RIGIDLOOP2324482324482015-09-01
10886705024117RIGIDLOOP2324492324492015-09-01
10886705026012TRUESPAN ORTHOCORD2281512281512016-07-07
10886705026029TRUESPAN ORTHOCORD2281522281522016-07-07

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B366U1VI3111PROCAM FULL PALEclerisFWF2022-06-30
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