FDA UDI
In Commercial Distribution
🇺🇸 United States
LensHooke Semen Analysis System
DI: 14719874743458
·
Model: X12 Package-1pcs-US HT(Plug UL)/RX
·
BONRAYBIO CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LensHooke Semen Analysis System
- Primary DI
- 14719874743458
- Version / Model
- X12 Package-1pcs-US HT(Plug UL)/RX
- Catalog Number
- X12 PRO
- Company Name
- BONRAYBIO CO., LTD.
- Labeler DUNS
- 658872369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-01
- Public Version
- 1
- Public Version Date
- 2025-09-09
- Public Version Status
- New
- Public Device Record Key
- 61d0710b-15f5-40d4-bb3f-195dfc664c54
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| POV | Semen Analysis Device | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57855 | Spermatozoa/semen analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of a semen specimen to assess volume, spermatozoa concentration, motility and/or morphological characteristics. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14719874743458 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242388 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 38 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- – 70 Percent (%) Relative Humidity