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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDP | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44883 | Dental implant/prosthesis surgical procedure kit | A collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D745701066MNI00011 | HIBCC | ||||
| Unit of Use | D745701066MNI00010 | HIBCC |
Customer Contacts
- Phone
- +1(949)440-2629
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3.2 | Millimeter |