FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent
DI: D832IPM4CD0
·
Model: IPM-4CD
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Plasdent
- Primary DI
- D832IPM4CD0
- Version / Model
- IPM-4CD
- Catalog Number
- IPM-4CD
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-25
- Public Version
- 1
- Public Version Date
- 2022-02-02
- Public Version Status
- New
- Public Device Record Key
- dca50926-00a2-4655-8b86-43ef3bda9743
Device Description
Occlusal Contraster
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 |
|---|---|---|---|---|
| NRD | Unit, Operative Dental, Accessories | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14066 | Tongue depressor, surgical | A hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D832IPM4CD0 | HIBCC |