FDA UDI In Commercial Distribution 🇺🇸 United States

3D Dental- Bioviva

DI: 00817169021964 · Model: BHG · 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
3D Dental- Bioviva
Primary DI
00817169021964
Version / Model
BHG
Company Name
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Labeler DUNS
080194935
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-30
Public Version
2
Public Version Date
2020-07-07
Public Version Status
Update
Public Device Record Key
4c0501fd-1c05-434f-8711-02e31bbd469c

Device Description

Bioviva Soluble Dental Hemostatic Gauze

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
No
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
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

GMDN Terms

Code Name
63636 General oral wound dressing, non-animal-derived, sterile

Identifiers

Type ID
Primary 00817169021964