SpyGlass

Primary DI
08714729779667
Brand
SpyGlass
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00546240
Device description
Isolation Transformer
Published
2016-09-24
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
FFYAdaptor, bulbs, miscellaneous, for endoscope

Product Code Classifications

CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08714729779667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08714729779667087147297796678714729779667

GMDN Terms

TermDefinition
Basic transformerA device designed to be used in a mains electricity alternating current (AC) circuit to increase (step-up) or decrease (step-down) voltage, to provide the specified voltage to a parent device; it is not a built-in component of the parent device. It provides galvanic insulation between the mains current and the equipment and has separate primary (input) and secondary (output) coils.

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
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
false

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