FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuThrive®
DI: 00843382113827
·
Model: Biopsy Blade
·
AccuTec, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AccuThrive®
- Primary DI
- 00843382113827
- Version / Model
- Biopsy Blade
- Catalog Number
- AVSC-1135-0000
- 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
- e8b0eefd-2fbe-4bd7-afa1-54d6d8bfbd4d
Device Description
ACCUTHRIVE DERMABLADE BIOPSY BLADE SS STERILE USA 400BL/CA (50BL/CT, 8CT/CS)
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
- Yes
- 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 |
|---|---|---|---|---|
| 63028 | Skin biopsy blade | A sterile hand-held device intended to be used to surgically remove a tissue specimen from a patient’s skin for histopathological examination (biopsy); it may also be used to remove skin lesions (e.g., skin moles). Sometimes referred to as a biopsy razor blade, it is in the form of a cutting blade, within a plastic case with side grips, which is flexible to help facilitate bending for precise tissue excision. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00843382113834 | GS1 | Inner | 50 | In Commercial Distribution | |
| Primary | 00843382113827 | GS1 | ||||
| Package | 00843382113841 | GS1 | Case | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- (800) 336-4061
- [email protected]