FDA UDI Not in Commercial Distribution 🇺🇸 United States

TINY® IMPLANT Ø3,75 ↕15

DI: 08435389806745 · Model: IRT3715 · BIOTECHNOLOGY INSTITUTE SL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TINY® IMPLANT Ø3,75 ↕15
Primary DI
08435389806745
Version / Model
IRT3715
Company Name
BIOTECHNOLOGY INSTITUTE SL
Labeler DUNS
461665312
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-10-17
Public Version
4
Public Version Date
2022-12-05
Public Version Status
Update
Public Device Record Key
09947cfc-d8a9-4390-8ac2-c4d3996ca9a7
Distribution End Date
2017-06-13

Device Characteristics

Single Use
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
DZE Implant, Endosseous, Root-Form

GMDN Terms

Code Name
55849 Screw endosteal dental implant, two-piece

Identifiers

Type ID
Primary 08435389806745

Customer Contacts

Phone
2156464067

Device Sizes

Type Value Unit Text
Length 15 Millimeter
Outer Diameter 3.75 Millimeter