FDA UDI In Commercial Distribution 🇺🇸 United States

Guided Surgery Drills KIT - Basic

DI: 07290109301174 · Model: GSK001 · ADIN DENTAL IMPLANT SYSTEMS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Guided Surgery Drills KIT - Basic
Primary DI
07290109301174
Version / Model
GSK001
Company Name
ADIN DENTAL IMPLANT SYSTEMS LTD
Labeler DUNS
533289435
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-08
Public Version
1
Public Version Date
2020-12-16
Public Version Status
New
Public Device Record Key
58a3b63b-5401-40ec-b6d1-73da33dfa50c

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
Yes
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
OFY Dental Implant Surgical Tray

GMDN Terms

Code Name
45147 Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Identifiers

Type ID
Primary 07290109301174