| Z-0028-2013 |
Remington Medical Inc. |
2
|
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005.
Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement. |
| Z-0042-2014 |
Atossa Genetics, Inc. |
2
|
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy.
The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes:
PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5.
PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD.
THE MASCT SYSTEM KIT CONSISTS OF:
1. MASCT Breast Pump;
2. Instructions for Use (IFU);
3. Heating Pad;
4. Timer;
5. Saccomono's Fixative;
6. Nu Prep Gel;
7. Welcome and Training Materials Coversheet;
8. MASCT System Order Form;
9. ForeCYTE Training Video DVD;
10. MASCT System Instructions with pictures - pink;
THE PATIENT SAMPLE KIT CONSISTS OF:
1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder);
2. Instructions for Use (IFU);
3. Two (2) specimen collection devices;
4. Two (2) breast bags for transporting the specimen collection container;
5. Barcode labels;
6. Saccomono's Fixative;
7. Nu Prep Gel;
8. MASCT System package insert;
9. ForeCYTE Test Requisition Form;
10. Patient Information Sheet;
11. Atossa Patient Information;
12. FED EX Clinical PAK;
13. MASCT System Order Form;
14. FED EX Pouch;
15. FED EX Airbill;
Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells. |
| Z-0044-2018 |
Bard Peripheral Vascular Inc |
2
|
BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm.
The core needle biopsy device is intended for use in obtaining biopsies from soft tissues. |