FDA UDI Not in Commercial Distribution 🇺🇸 United States

Argus ll Camera Rotation Tool

DI: 00856264005509 · Model: 014993-000 · Second Sight Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Argus ll Camera Rotation Tool
Primary DI
00856264005509
Version / Model
014993-000
Catalog Number
014993
Company Name
Second Sight Medical Products, Inc.
Labeler DUNS
086470742
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-05-06
Public Version
4
Public Version Date
2023-05-19
Public Version Status
Update
Public Device Record Key
6eb1b591-bc5f-40ff-9ede-d277b02c7ac4
Distribution End Date
2023-03-31

Device Description

Tool used to rotate the camera on the glasses during during the camera alignment procedure.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NBF Prosthesis,Retinal

GMDN Terms

Code Name
58524 Retinal prosthesis system tester/clinical evaluator

Identifiers

Type ID
Primary 00856264005509

Customer Contacts

Phone
818-833-5027

Premarket Submissions

Submission Number Supplement Number
H110002 000