FDA UDI In Commercial Distribution 🇺🇸 United States

TotalEndo GATES Glidden drills

DI: D716TEGG6281 · Model: TEGG628 · TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TotalEndo GATES Glidden drills
Primary DI
D716TEGG6281
Version / Model
TEGG628
Catalog Number
TEGG628
Company Name
TULSA DENTAL PRODUCTS LLC
Labeler DUNS
942778564
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-26
Public Version
1
Public Version Date
2022-09-05
Public Version Status
New
Public Device Record Key
16352397-e61d-4d1d-b66a-bf0f7094b039

Device Description

Total Endo Gates Glidden Drill #6 28MM

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
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
EKS FILE, PULP CANAL, ENDODONTIC

GMDN Terms

Code Name
40529 Rotary/reciprocating endodontic file/rasp, reusable

Identifiers

Type ID
Primary D716TEGG6281