FDA UDI
In Commercial Distribution
🇺🇸 United States
SAFE DENT
DI: 00810339031343
·
Model: C6060
·
BGSS Company Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1000
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Basic Information
- Brand Name
- SAFE DENT
- Primary DI
- 00810339031343
- Version / Model
- C6060
- Company Name
- BGSS Company Inc.
- Labeler DUNS
- 828474952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2024-05-01
- Public Version
- 1
- Public Version Date
- 2024-05-09
- Public Version Status
- New
- Public Device Record Key
- e4a9af55-cdbb-4745-8935-f87f4b00603b
Device Description
6" cotton tipped applicators
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33722 | General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810339031350 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00810339031343 | GS1 | ||||
| Unit of Use | 10810339031333 | GS1 |