FDA UDI
In Commercial Distribution
🇺🇸 United States
LensHooke X QC Reticle (For Semen)
DI: 04719874740870
·
Model: X QC Reticle - 3 in1_BR USA CORP.
·
BONRAYBIO CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LensHooke X QC Reticle (For Semen)
- Primary DI
- 04719874740870
- Version / Model
- X QC Reticle - 3 in1_BR USA CORP.
- Catalog Number
- X QC Reticle
- Company Name
- BONRAYBIO CO., LTD.
- Labeler DUNS
- 658872369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-16
- Public Version
- 1
- Public Version Date
- 2020-03-24
- Public Version Status
- New
- Public Device Record Key
- 552fe199-5652-462c-8f35-c65b621b1129
Device Description
04719874740887 LensHooke X QC Reticle (For Semen)-L0 04719874740894 LensHooke X QC Reticle (For Semen)-L1 04719874740900 LensHooke X QC Reticle (For Semen)-L2 For BR USA CORP.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| NRF | Material, Quality Control, Semen Analysis | Hematology | 864.8625 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61075 | Sperm concentration indicator IVD, control | A material that is used to verify the performance of an assay intended to be used to indicate the concentration of sperm in a semen specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719874740870 | GS1 |