FDA UDI In Commercial Distribution 🇺🇸 United States

Reusable Kit

DI: 00850470007241 · Model: Site Making · RESTORATION ROBOTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Reusable Kit
Primary DI
00850470007241
Version / Model
Site Making
Catalog Number
FP-46446
Company Name
RESTORATION ROBOTICS, INC.
Labeler DUNS
627212587
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-17
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
8ddc8b09-0918-4fe9-8020-cba8a5f77229

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
ONA Computer Assisted Hair Harvesting System

GMDN Terms

Code Name
35290 Hair extraction punch

Identifiers

Type ID
Primary 00850470007241