FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuThrive®
DI: 00843382109257
·
Model: Shave Biopsy Kit
·
AccuTec, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AccuThrive®
- Primary DI
- 00843382109257
- Version / Model
- Shave Biopsy Kit
- Catalog Number
- AVAN-5000-0000
- 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
- 04994064-ab3f-4b8e-a2dc-d0b0da2acb53
Device Description
ACCUTHRIVE DERMABLADE SHAVE BIOPSY KIT 1BL/KIT (10KIT/CA)
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 |
|---|---|---|---|---|
| LRO | General Surgery Tray | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33961 | General surgical procedure kit, non-medicated, single-use | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00843382113810 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00843382109257 | GS1 |
Customer Contacts
- Phone
- (800) 336-4061
- [email protected]