FDA UDI In Commercial Distribution 🇺🇸 United States

SURGICAL INSTRUMENTATION

DI: 07290110723866 · Model: T-BT-4.1 · HI-TEC IMPLANTS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SURGICAL INSTRUMENTATION
Primary DI
07290110723866
Version / Model
T-BT-4.1
Catalog Number
T-BT-4.1
Company Name
HI-TEC IMPLANTS LTD.
Labeler DUNS
600710917
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-06-07
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
6a8e9cd1-ea56-480c-bf57-dce753d8863b

Device Description

BONE TAP

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
No
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", "Liquid Chemical"]

Product Codes

Code Name
NHA Abutment, Implant, Dental, Endosseous

GMDN Terms

Code Name
44883 Dental implant/prosthesis surgical procedure kit

Identifiers

Type ID
Primary 07290110723866