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12 mm x 21 mm MACI Cutter
VERICEL CORPORATION
82029
In Commercial Distribution
- 00860004093077 ()
N/A
- Surgical implant template, single-use
17 mm x 28 mm Max Arthroscopic Cutter
VERICEL CORPORATION
82028
In Commercial Distribution
- 00860004093060 ()
N/A
- Bone curette, single-use
14 mm x 26 mm Max Arthroscopic Cutter
VERICEL CORPORATION
82027
In Commercial Distribution
- 00860004093053 ()
N/A
- Bone curette, single-use
12 mm x 21 mm Min arthroscopic cutter
VERICEL CORPORATION
82025
In Commercial Distribution
- 00860004093046 ()
N/A
- Bone curette, single-use
18mm x 4cm Cannula assembly
VERICEL CORPORATION
82018
In Commercial Distribution
- 00860004093039 ()
N/A
- Arthroscopic access cannula, single-use
15mm x 4cm Cannula Assembly
VERICEL CORPORATION
82017
In Commercial Distribution
- 00860004093022 ()
N/A
- Arthroscopic access cannula, single-use
10 Panel Drug Test Cup – AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, THC
DEUS VULT, LLC
P33-10-MET
Not in Commercial Distribution
- 00860004081661 ()
- 00860004081654 ()
- 00860004081647 ()
P33-10-MET
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Multi-panel Drug Test Cup
DEUS VULT, LLC
PF12P
Not in Commercial Distribution
- 00860004081609 ()
- 00860004081616 ()
- 00860004081623 ()
- 00860004081630 ()
PF12P
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body when radiation treatment is indicated, while minimizing the delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the physician approved plan. The RefleXion Medical Radiotherapy System is also indicated for FDG-guided treatment which includes modeling, planning and precise delivery of FDG-guided radiation therapy, a type of Biology-guided Radiotherapy (BgRT), in five or fewer fractions for adults. It is indicated for tumor volumes in lung and bone subject to potential motion and positional uncertainty that have each been assessed with on-board PET/CT prior to delivery for adequate localization, sufficient FDG metabolic activity, local contrast and consistent biodistribution to meet the RMRS requirements, while minimizing the delivery of radiation to vital healthy tissue. BgRT involves the detection of signals from F18 during active beam delivery as a guide to deliver megavoltage X-ray radiotherapy in a rotational, modulated format in accordance with a physician approved treatment plan. For complete fludeoxyglucose F18 prescribing information, refer both to the current medical imaging agent labeling and to this device labeling under “FDG Medical Imaging Agent Information”.
REFLEXION MEDICAL, INC.
RXM1000
In Commercial Distribution
- 00860003983812 ()
- Linear accelerator system
CapMedic is an interactive smart inhaler add-on that provides guidance for correct and regular use. The Bluetooth-connected device can also perform PEF and FEV1 tests to track lung function.
Cognita Labs, LLC
CAPMED-C
In Commercial Distribution
- 00860003953709 ()
- Inhaler dose sensor
- Diagnostic spirometer, professional