FDA UDI In Commercial Distribution 🇺🇸 United States

4/5/6mm Crown & Bridge Driver

DI: D7850075NS0 · Model: 4/5/6mm C&B Driver (Short) · OCO BIOMEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
4/5/6mm Crown & Bridge Driver
Primary DI
D7850075NS0
Version / Model
4/5/6mm C&B Driver (Short)
Catalog Number
0075NS
Company Name
OCO BIOMEDICAL INC
Labeler DUNS
094146123
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-04-21
Public Version
3
Public Version Date
2024-02-23
Public Version Status
Update
Public Device Record Key
191ae7c0-7081-41fb-8a77-133fb0c41265

Device Description

4/5/6mm C&B Driver (Short) Places 4/5mm ISI C&B Implants and 4/5mm Solid Abutments for TSI/ERI/Macro

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
33968 Surgical screwdriver, reusable

Identifiers

Type ID
Primary D7850075NS0