FDA UDI
In Commercial Distribution
🇺🇸 United States
Inclusive®
DI: D745701071SRG03850
·
Model: 70-1071-SRG0385
·
Prismatik Dentalcraft, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Inclusive®
- Primary DI
- D745701071SRG03850
- Version / Model
- 70-1071-SRG0385
- Catalog Number
- 70-1071-SRG0385
- Company Name
- Prismatik Dentalcraft, Inc
- Labeler DUNS
- 022761689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-15
- Public Version
- 1
- Public Version Date
- 2025-05-23
- Public Version Status
- New
- Public Device Record Key
- 47e33ab5-5155-475c-8ec1-4e8c85a326a0
Device Description
Inclusive® Fixation Guide Sleeve Ø1.5 for 15 mm
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
- Yes
- Sterilization Methods
- High-level Disinfectant
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 |
|---|---|---|---|---|
| 64371 | Dental implantation drilling template guide-sleeve | A small tubular device intended to be inserted within the guide holes of a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation) to guide the implant into position. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D745701071SRG03850 | HIBCC |