FDA UDI In Commercial Distribution 🇺🇸 United States

Disposable Kits

DI: 00850470007340 · Model: 18G 4 Prong 4mm Punch · RESTORATION ROBOTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Disposable Kits
Primary DI
00850470007340
Version / Model
18G 4 Prong 4mm Punch
Catalog Number
FP-47845
Company Name
RESTORATION ROBOTICS, INC.
Labeler DUNS
627212587
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-08
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
00e6f555-6c25-477f-a9c1-0ac55262958f

Device Characteristics

Single Use
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
ONA Computer Assisted Hair Harvesting System

GMDN Terms

Code Name
35290 Hair extraction punch

Identifiers

Type ID
Primary 00850470007340