FDA UDI In Commercial Distribution 🇺🇸 United States

BIONNOVATION

DI: 07899943601244 · Model: 13136 · BIONNOVATION PRODUTOS BIOMEDICOS LTDA.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BIONNOVATION
Primary DI
07899943601244
Version / Model
13136
Catalog Number
13136
Company Name
BIONNOVATION PRODUTOS BIOMEDICOS LTDA.
Labeler DUNS
903266968
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-03-23
Public Version
1
Public Version Date
2023-03-31
Public Version Status
New
Public Device Record Key
16d48e99-6d31-45ea-8d87-37bba4593c50

Device Description

DRIVE LOCK IMPLANT BIOMORSE LONG

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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
DZN Instruments, Dental Hand

GMDN Terms

Code Name
32871 Surgical torque wrench, reusable

Identifiers

Type ID
Primary 07899943601244