FDA UDI
In Commercial Distribution
🇺🇸 United States
LensHooke Liquefaction Enzyme
DI: 04719874741259
·
Model: CK1 Package-10pcs-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 Liquefaction Enzyme
- Primary DI
- 04719874741259
- Version / Model
- CK1 Package-10pcs-BR USA CORP.
- Catalog Number
- CK1
- Company Name
- BONRAYBIO CO., LTD.
- Labeler DUNS
- 658872369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-13
- Public Version
- 1
- Public Version Date
- 2025-02-21
- Public Version Status
- New
- Public Device Record Key
- 26240205-cb27-4ae0-955e-ef1cd3047c68
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| IBG | Trypsin | Pathology | 864.4400 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42703 | Specimen preparation enzyme reagent IVD | An enzymatic substance or reactant intended to be used alone or in combination with other IVDs for the liquefication or digestion of clinical laboratory specimens containing mucoid or clumped material in preparation for further processing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719874741259 | GS1 |