FDA UDI
In Commercial Distribution
🇺🇸 United States
ACU-SABOURAUD
DI: 10814105021221
·
Model: M103
·
ACUDERM, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- ACU-SABOURAUD
- Primary DI
- 10814105021221
- Version / Model
- M103
- Company Name
- ACUDERM, INC.
- Labeler DUNS
- 071426803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2020-09-22
- Public Version
- 1
- Public Version Date
- 2020-09-30
- Public Version Status
- New
- Public Device Record Key
- 35b75f6f-87dd-4913-94b0-14d6b37f185e
Device Description
ACU-SABOURAUD, 24/Bx
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | Microbiology | 866.2360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42734 | Dextrose utilization microbial reagent IVD | A substance or reactant intended to be used in microbial testing to determine the ability of a microorganism isolated from a clinical specimen by culture to ferment the carbohydrate dextrose. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00814105021224 | GS1 | ||||
| Primary | 10814105021221 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K832583 | 000 |