FDA.report

RoboticScope

Primary DI
B8581023121
Brand
RoboticScope
Company
BHS Technologies GmbH
Model
1.5
Catalog number
102312
Device description
Active medical device used for digital, surgical microscopy. The RoboticScope is intended to be used for illumination and enlarged visualization of the surgical area.
Published
2024-04-03
Public version status
New
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
FSOMicroscope, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
FSOMicroscope, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B8581023121PrimaryHIBCC0

GMDN Terms

TermDefinition
General-purpose surgical microscopeA general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure800 millibar1100 millibar
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Keep dry
Storage Environment Atmospheric Pressure500 millibar1100 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1 (475) 329 8201office@bhs-technologies.com

Regulatory Flags

DUNS number
300519551
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
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B858138821RoboticScope1.5138822024-04-03

Other Devices Sharing Product Codes

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06977585090013OPMI LUMERA 300Carl Zeiss Meditec (Suzhou) Co., Ltd.FSO2025-03-26
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