FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuThrive®
DI: 00843382104054
·
Model: Microtome Blade
·
AccuTec, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AccuThrive®
- Primary DI
- 00843382104054
- Version / Model
- Microtome Blade
- Catalog Number
- AVBL-2010-0000
- Company Name
- AccuTec, Inc.
- Labeler DUNS
- 079966794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-17
- Public Version
- 1
- Public Version Date
- 2024-12-25
- Public Version Status
- New
- Public Device Record Key
- bbe2f2c6-f002-40c1-9b62-6c2594891213
Device Description
AccuThrive Longevity Microtome Blade Low Profile SS Microcoat 100BL/CA (10BL/DISP, 10 DISP/CA)
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| IDL | Microtome, Accessories | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42440 | Microtome blade IVD, single-use | A flat, wedge-shaped, sharp blade intended to be mounted into a microtome to cut micro-thin slices of tissue that has been fixed, and usually impregnated, with paraffin wax. The resulting sections are mounted onto slides for staining and then viewing with a microscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10843382104051 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00843382104054 | GS1 |
Customer Contacts
- Phone
- (800) 336-4061
- [email protected]