FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearSpec
DI: 20860008900368
·
Model: 105
·
Clearspec LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClearSpec
- Primary DI
- 20860008900368
- Version / Model
- 105
- Catalog Number
- 105
- Company Name
- Clearspec LLC
- Labeler DUNS
- 075061406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-29
- Public Version
- 1
- Public Version Date
- 2025-11-06
- Public Version Status
- New
- Public Device Record Key
- 509f445b-cc33-4e77-addd-76d828a3c14b
Device Description
ClearSpec LED Speculum Illuminator - case
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYT | Light, Examination, Medical, Battery Powered | General Hospital | 880.6350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46960 | Vaginal illuminator | A device used to illuminate the vagina during a gynaecological examination or procedure. It is typically a chemiluminescent illumination source that is attached to the upper dilator blade of a vaginal speculum. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20860008900368 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130046 | 000 |