FDA UDI In Commercial Distribution 🇺🇸 United States

Bioviva by 3D Dental

DI: 00810126503411 · Model: SCG687 · 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Bioviva by 3D Dental
Primary DI
00810126503411
Version / Model
SCG687
Catalog Number
SCG687
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
2023-12-04
Public Version
1
Public Version Date
2023-12-12
Public Version Status
New
Public Device Record Key
d6f62dbd-af38-4cfb-a844-f61cafebe57a

Device Description

BIOVIVA SUTURE CHROMIC GUT REVERSE CUTTING 5/0 P-3 3/8 18" 13MM

Device Characteristics

Single Use
Yes
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
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GAL Suture, Absorbable, Natural

GMDN Terms

Code Name
45025 Catgut suture, chromic

Identifiers

Type ID
Package 10810126503418
Primary 00810126503411