FDA UDI In Commercial Distribution 🇺🇸 United States

GoldenDent

DI: 00850011211014 · Model: FS BFE · GoldenDent
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
GoldenDent
Primary DI
00850011211014
Version / Model
FS BFE
Catalog Number
FS BFE
Company Name
GoldenDent
Labeler DUNS
078273228
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-02-25
Public Version
1
Public Version Date
2021-03-05
Public Version Status
New
Public Device Record Key
e64b6cf8-fe26-45f7-9a02-d50522be6f39

Device Description

Broken File Extraction Intro Kit: Included 45, 75, 90 & 100 degree retrieval probes

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
Combination Product
Yes
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
EKS FILE, PULP CANAL, ENDODONTIC

GMDN Terms

Code Name
31814 Dental dressing forceps, reusable

Identifiers

Type ID
Primary 00850011211014