DEVICE: Argus ll Operating Room Coil (00856264005387)

Download: XML | JSON

Device Identifier (DI) Information

Argus ll Operating Room Coil
012103-003
012103
Second Sight Medical Products, Inc.
00856264005387
GS1
1
The operating room coil is used during surgery in replacement of the glasses. A telemetry coil and radio-frequency system are mounted on the device to provide communication between the implant and the VPU during surgery.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Retinal prosthesis system implantation test coil A radio-frequency coil that is a component of a retinal prosthesis system designed for intraoperative testing of the implant. Typically it is used in the operating room (OR) by a surgeon or other healthcare personnel.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NBF Prosthesis,Retinal
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 32 and 113 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
May 06, 2015

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
818-833-5023
customerservice@secondsight.com
CLOSE