FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00810047421061
·
Model: 745-1
·
Scientific Device Laboratory, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00810047421061
- Version / Model
- 745-1
- Company Name
- Scientific Device Laboratory, Inc.
- Labeler DUNS
- 115927956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-31
- Public Version
- 1
- Public Version Date
- 2023-02-08
- Public Version Status
- New
- Public Device Record Key
- 766e30e3-525c-47f9-b8bc-fcf2f7ca160e
Device Description
Mycology Mounting Set BLUE [1 Fungitape - 1 Mycoperm blue/set]
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
- 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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
| KEQ | Media, Mounting, Water Soluble | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43550 | Microscopy mounting medium IVD | A substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip to preserve the specimen and enhance image quality during microscopic examination. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810047421061 | GS1 |