FDA UDI
Not in Commercial Distribution
🇺🇸 United States
General Biopsy Tray
DI: 00886333217403
·
Model: CG00552
·
ARGON MEDICAL DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- General Biopsy Tray
- Primary DI
- 00886333217403
- Version / Model
- CG00552
- Catalog Number
- CG00552
- Company Name
- ARGON MEDICAL DEVICES, INC.
- Labeler DUNS
- 140727624
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-20
- Public Version
- 2
- Public Version Date
- 2024-01-31
- Public Version Status
- Update
- Public Device Record Key
- a5bf2dc2-dd0b-4f9a-a36c-617519859f43
- Distribution End Date
- 2024-01-30
Device Description
Custom General Biopsy Tray for University of Rochester Medical Center
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OJT | Aspiration Tray | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61922 | Soft-tissue biopsy procedure kit, medicated | A collection of sterile devices, which includes a pharmaceutical(s), designed to perform a non-specific soft tissue biopsy (e.g., skin biopsy, breast biopsy); it is not dedicated to biopsy of a specific internal organ. It includes the biopsy needle used for this procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20886333217407 | GS1 | Box | 5 | Not in Commercial Distribution | 2024-01-30 |
| Primary | 00886333217403 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool place and avoid temperature extremes