FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent
DI: D832SESNAP2P1
·
Model: SE-SNAP-2P
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Plasdent
- Primary DI
- D832SESNAP2P1
- Version / Model
- SE-SNAP-2P
- Catalog Number
- SE-SNAP-2P
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2022-02-14
- Public Version
- 1
- Public Version Date
- 2022-02-22
- Public Version Status
- New
- Public Device Record Key
- e08606f1-2cc6-4af2-92f1-49e33643d15a
Device Description
Snap Sensor Holder, Blue Ocean
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EGZ | Holder, Film, X-Ray | Dental | 872.1905 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43266 | Sensor holder, reusable | A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position. This device will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body during computer assisted surgery (CAS), another device, or a suitable place in the vicinity of use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D832SESNAP2P0 | HIBCC | ||||
| Primary | D832SESNAP2P1 | HIBCC |