FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent
DI: D832CTR021
·
Model: CTR-02
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2000
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Basic Information
- Brand Name
- Plasdent
- Primary DI
- D832CTR021
- Version / Model
- CTR-02
- Catalog Number
- CTR-02
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2000
- Record Status
- Published
- Publish Date
- 2022-03-24
- Public Version
- 1
- Public Version Date
- 2022-04-01
- Public Version Status
- New
- Public Device Record Key
- a6201f9b-8c4d-4071-bfdd-d3341559cb32
Device Description
Cotton Rolls, Non-Sterile, #2
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
- 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 |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31815 | Dental cotton roll | A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D832CTR022 | HIBCC | Case | 12 | In Commercial Distribution | |
| Primary | D832CTR021 | HIBCC | ||||
| Unit of Use | D832CTR020 | HIBCC |