FDA UDI
In Commercial Distribution
🇺🇸 United States
Dental City
DI: D77146117
·
Model: 46-117
·
ICP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2000
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Basic Information
- Brand Name
- Dental City
- Primary DI
- D77146117
- Version / Model
- 46-117
- Company Name
- ICP, INC.
- Labeler DUNS
- 808371371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2000
- Record Status
- Published
- Publish Date
- 2021-06-25
- Public Version
- 2
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 1a7d6a61-31c8-48eb-8595-0d60a8a1032a
Device Description
Dental City Cotton Rolls #2 Medium 2000/Box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFN | Cotton, Roll | Dental | 872.6050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58232 | Cotton wool roll | A device designed as an absorbent mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector or the home; it is not in the form of a bandage or dedicated dressing. 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 | D771461170 | HIBCC | ||||
| Primary | D77146117 | HIBCC |