FDA.report

DYONICS

Primary DI
03596010450005
Brand
DYONICS
Company
Smith & Nephew, Inc.
Model
7205841S
Catalog number
7205841S
Device description
SERVICE REP CONTROL UNIT ASSEMBLY
Published
2017-06-15
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
HRXArthroscope

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010450005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010450005035960104500053596010450005

GMDN Terms

TermDefinition
Camera control unitA mains electricity (AC-powered) unit intended to be used to remotely steer a camera's movements and adjustments (e.g., a miniaturized camera) in a clinical setting. It is typically situated outside the field of operation and can be adjusted upon instructions from the surgeon/operator, or it may be automated to a certain degree. Some remote control units may have extensive functions and may supply the camera with electric current and adjustments such as light intensity, colour control, automatic exposure, and automatic flash. Those types used in ophthalmology may operate the raise/lower function of the ophthalmic instrument table upon which the camera is situated.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
false
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
false

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