FDA UDI In Commercial Distribution 🇺🇸 United States

MIS 4BONE

DI: 07290108991048 · Model: 4B-C3040 · MIS Implants Technologies Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MIS 4BONE
Primary DI
07290108991048
Version / Model
4B-C3040
Company Name
MIS Implants Technologies Ltd.
Labeler DUNS
514576057
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-15
Public Version
3
Public Version Date
2022-05-17
Public Version Status
Update
Public Device Record Key
bcffffce-6595-45c5-9205-3586c9418124

Device Description

MIS 4Bone RCB Resorbable Conforming Barrier Membrane

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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
NPL Barrier, Animal Source, Intraoral

GMDN Terms

Code Name
58709 Collagen dental regeneration membrane

Identifiers

Type ID
Primary 07290108991048