FDA UDI In Commercial Distribution 🇺🇸 United States

Driver Hex 1.25mm long

DI: 07290119310708 · Model: 8mm Diameter x 28.6mm Length · BIOLINE DENTAL IMPLANT SYSTEMS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Driver Hex 1.25mm long
Primary DI
07290119310708
Version / Model
8mm Diameter x 28.6mm Length
Catalog Number
BIO-X1007
Company Name
BIOLINE DENTAL IMPLANT SYSTEMS LTD
Labeler DUNS
532209134
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-03-21
Public Version
2
Public Version Date
2025-07-02
Public Version Status
Update
Public Device Record Key
7cd4f03f-2d9b-4d69-ba81-df70114f9dee

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
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
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
55847 Dental implant system

Identifiers

Type ID
Primary 07290119310708