FDA UDI In Commercial Distribution 🇺🇸 United States

INTERNA® IMPLANT EXTENSOR , 29 MM

DI: 08435389806844 · Model: EAI29 · BIOTECHNOLOGY INSTITUTE SL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
INTERNA® IMPLANT EXTENSOR , 29 MM
Primary DI
08435389806844
Version / Model
EAI29
Company Name
BIOTECHNOLOGY INSTITUTE SL
Labeler DUNS
461665312
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-11-16
Public Version
2
Public Version Date
2023-05-03
Public Version Status
Update
Public Device Record Key
41d6a9fa-efc7-4946-8e06-9ef0a9b8b95b

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
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
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
47847 Orthopaedic implant-instrument extension adaptor, reusable

Identifiers

Type ID
Primary 08435389806844