FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent
DI: D832CTRS5401
·
Model: CTR-S540
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
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Basic Information
- Brand Name
- Plasdent
- Primary DI
- D832CTRS5401
- Version / Model
- CTR-S540
- Catalog Number
- CTR-S540
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2024-11-12
- Public Version
- 1
- Public Version Date
- 2024-11-20
- Public Version Status
- New
- Public Device Record Key
- 21e76056-f70e-4d3b-8244-b88f60cc1166
Device Description
Cotton Rolls, EO Gas 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | D832CTRS5400 | HIBCC | ||||
| Primary | D832CTRS5401 | HIBCC |