FDA UDI
In Commercial Distribution
🇺🇸 United States
PiezoImplant System
DI: D894SK270
·
Model: Removal Carrier BL 2.9
·
Rex Implants, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PiezoImplant System
- Primary DI
- D894SK270
- Version / Model
- Removal Carrier BL 2.9
- Catalog Number
- SK-27
- Company Name
- Rex Implants, Inc.
- Labeler DUNS
- 080746478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-17
- Public Version
- 1
- Public Version Date
- 2024-06-25
- Public Version Status
- New
- Public Device Record Key
- 0f84eef0-e7ac-479e-bd03-fa5b3fec43c3
Device Description
Removal Carrier BL 2.9
Device Characteristics
- Single Use
- No
- 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
- 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
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 45319 | Dental implant extractor | A manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typically has a cylindrical design and a cavity or threaded shaft at the working distal end intended to grip or be inserted into the implant. It may have a handle at the proximal end or be used in conjunction with a drill and/or a separate handle or wrench (not included); it is not a collection of devices (i.e., not a kit). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D894SK270 | HIBCC |