FDA UDI
In Commercial Distribution
🇺🇸 United States
EDGE BIOLOGICALS INC
DI: B6454P124
·
Model: 4P124
·
EDGE BIOLOGICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EDGE BIOLOGICALS INC
- Primary DI
- B6454P124
- Version / Model
- 4P124
- Company Name
- EDGE BIOLOGICALS, INC.
- Labeler DUNS
- 047927827
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-07
- Public Version
- 2
- Public Version Date
- 2023-08-18
- Public Version Status
- Update
- Public Device Record Key
- f34160df-916d-4645-87e0-dcd21f9ba237
Device Description
DERMATOPHYTE TEST MEDIUM (DTM) AGAR
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSI | Culture Media, Selective And Differential | Microbiology | 866.2360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43344 | Tissue culture/microbiology petri dish, single-use | A device formed as a round and shallow-sided dish intended to be used to grow and contain tissue and/or microbial cultures for laboratory procedures; it is not intended for in vitro fertilization (IVF). It is designed to fit into a range of laboratory instruments and analysers where various processes can be carried out. The device is typically made of glass or plastic and includes a cover; it may be colour coded. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B6454P124 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius