FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Table Top MicroHood
DI: 58050148211360
·
Model: W087-014
·
COPAN WASP SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Table Top MicroHood
- Primary DI
- 58050148211360
- Version / Model
- W087-014
- Catalog Number
- W087-014
- Company Name
- COPAN WASP SRL
- Labeler DUNS
- 434263590
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-27
- Public Version
- 2
- Public Version Date
- 2021-07-16
- Public Version Status
- Update
- Public Device Record Key
- c9fea808-bb5a-4240-8560-833cd718d05b
- Distribution End Date
- 2021-07-15
Device Description
Table Top MicroHood
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
- Yes
- 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 |
|---|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | Clinical Chemistry | 862.2100 | 1 |
| JTQ | Bath, Incubators/Water, All | Microbiology | 866.2540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 20652 | Class-I biological safety cabinet | A furniture-like device designed as a partial or total enclosure to provide a class I biosafety level (BSL) to the operator and the environment during the manipulation of microorganisms and other biological hazardous materials (usually up to category 3 pathogens). It typically utilizes laminar airflow (LAF), a high-efficiency particulate air (HEPA) filter and/or carbon filter, and may have a hydrogen peroxide (H2O2) connection as some of the protective mechanisms. It is used for handling cell cultures and human pathogens (e.g., bacteria, viruses, parasites) and other biohazardous materials, extremely toxic agents (e.g., chemotherapy drugs), and also for tissue culture and tumour virus work. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 58050148211360 | GS1 |
Customer Contacts
- Phone
- +390302687218
- [email protected]