FDA UDI In Commercial Distribution 🇺🇸 United States

GATE DRILLS

DI: 08806383544320 · Model: 28m/m 1 · DiaDent Group International
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
GATE DRILLS
Primary DI
08806383544320
Version / Model
28m/m 1
Catalog Number
531-101
Company Name
DiaDent Group International
Labeler DUNS
687789453
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-15
Public Version
1
Public Version Date
2020-06-23
Public Version Status
New
Public Device Record Key
b9f44091-fb2b-48db-9865-76c72bbab92f

Device Description

GATE DRILLS is used for time-saving preparation of the upper and middle part of non-curved canal or the straight part of curved canal effectively and creating the excellent access for Reamers and Files.

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
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
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
DZA Drill, Dental, Intraoral

GMDN Terms

Code Name
45714 Fixture/appliance dental drill bit, reusable

Identifiers

Type ID
Primary 08806383544320