FDA UDI
In Commercial Distribution
🇺🇸 United States
Tissue-Tek® Accu-Edge®
DI: 00615233012746
·
Model: 0203
·
SAKURA FINETEK U.S.A., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tissue-Tek® Accu-Edge®
- Primary DI
- 00615233012746
- Version / Model
- 0203
- Catalog Number
- 0203
- Company Name
- SAKURA FINETEK U.S.A., INC.
- Labeler DUNS
- 179135769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-10
- Public Version
- 1
- Public Version Date
- 2020-07-20
- Public Version Status
- New
- Public Device Record Key
- 2d4534b5-7e37-4201-9579-2002cabbd475
Device Description
Scale, Economy Grade
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37784 | Laboratory scale, mechanical | A mechanical instrument designed for general use in the clinical laboratory to determine the weight of bulk materials, solutions, or large discrete objects when it is not necessary to have the accuracy of a laboratory balance, when the weight is beyond the range of a laboratory balance, or to weigh specimens under special conditions (e.g., in fume hoods). It includes appropriate top surfaces, trays, or platforms. Its capacity may range from 0.5 to 200 kg (1 to 440 lb), with a readability between 1 to 100 g (0.0025 to 0.25 lb). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00615233012746 | GS1 |
Customer Contacts
- Phone
- +1(310)972-7800
- [email protected]