FDA UDI In Commercial Distribution 🇺🇸 United States

XS GATES

DI: 07640142421634 · Model: 03.140.10.604.GC · FKG Dentaire Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
XS GATES
Primary DI
07640142421634
Version / Model
03.140.10.604.GC
Catalog Number
03.140.10.604.GC
Company Name
FKG Dentaire Sàrl
Labeler DUNS
482884061
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-14
Public Version
1
Public Version Date
2022-08-22
Public Version Status
New
Public Device Record Key
ad2a2bb3-ce6a-42a2-82ec-544b932a8c74

Device Description

Gates 140, 15 mm, # 4, ultra-short, handle GC

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
Yes
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
DZA Drill, Dental, Intraoral

GMDN Terms

Code Name
31876 Endodontic enlarger, reusable

Identifiers

Type ID
Primary 07640142421634