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The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM2
In Commercial Distribution
- B201CGVM20 ()
- B201CGVM21 ()
- B201CGVM23 ()
- B201CGVM22 ()
CG-VM2
- Imaging lesion localization marker, external, single-use
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM
In Commercial Distribution
- B201CGVM2 ()
- B201CGVM1 ()
- B201CGVM0 ()
- B201CGVM3 ()
- Imaging lesion localization marker, external, single-use
The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
IB-STIM
01-1020
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
NeuroStim
01-1021
- Acupuncture electrical stimulation system
The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms
of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by
transillumination. NSS-2 BRIDGE stimulator is a battery-operated micro-stimulation appliance weighing approximately 5 grams
designed as a disposable product for a single use. The NSS-2 BRIDGE stimulator is placed behind the patient’s ear and
connected to stimulation needles on the auricle. NSS-2 BRIDGE stimulator offers regular therapy over several days. The
appliance transmits low-frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
Bridge
01-1017-NSS-2/BRIDGE
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-5555-01
Not in Commercial Distribution
- M717715655554 ()
- M717715655553 ()
- M717715655552 ()
- M717715655550 ()
7156-5555
- Synovial fluid supplementation medium
SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-4444-1
In Commercial Distribution
- M717715644440 ()
- M717715644442 ()
- M717715644443 ()
- M717715644444 ()
7156-4444
- Synovial fluid supplementation medium
Polyp Trap with screw top, fine-mesh screen and tube with connector.. Package of 10.
M D Technologies Inc.
PT20C-10
In Commercial Distribution
- B325PT20C100 ()
- B325PT20C101 ()
- B325PT20C252 ()
- B325PT20C503 ()
- B325PT20C1004 ()
PT20C10
- Surgical suction system collection container, single-use
Polyp Trap with screw top, fine-mesh screen and plain tube. Package of 10.
M D Technologies Inc.
PT20-10
In Commercial Distribution
- B325PT20252 ()
- B325PT20100 ()
- B325PT20503 ()
- B325PT201004 ()
- B325PT20101 ()
PT2010
- Surgical suction system collection container, single-use
Collection Assist Device that collects a clean sample from the female hansen port of a hemodialysis machine.
MOLDED PRODUCTS, INC.
MPC-745
In Commercial Distribution
- B144MPC7451 ()
- B144MPC7450 ()
- B144MPC7452 ()
- B144MPC7453 ()
MPC-745
- Haemodialysis treatment kit