FDA UDI In Commercial Distribution 🇺🇸 United States

Inclusive

DI: D745701066MNI00011 · Model: 70-1066-MNI0001 · Prismatik Dentalcraft, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25

Basic Information

Brand Name
Inclusive
Primary DI
D745701066MNI00011
Version / Model
70-1066-MNI0001
Catalog Number
70-1066-MNI0001
Company Name
Prismatik Dentalcraft, Inc
Labeler DUNS
022761689
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2016-10-07
Public Version
3
Public Version Date
2023-08-22
Public Version Status
Update
Public Device Record Key
f89a847f-e2c1-40a4-a777-ca19dc780871

Device Description

Inclusive Mini Implant Blockout Shims (25-Pack)

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
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
No

Product Codes

Code Name
NDP ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

GMDN Terms

Code Name
44883 Dental implant/prosthesis surgical procedure kit

Identifiers

Type ID
Primary D745701066MNI00011
Unit of Use D745701066MNI00010

Customer Contacts

Device Sizes

Type Value Unit Text
Outer Diameter 3.2 Millimeter