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The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8053108-100
In Commercial Distribution
- 10850011833770 ()
- 00850011833773 ()
- 80850011833779 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8052912-100
In Commercial Distribution
- 10850011833763 ()
- 00850011833766 ()
- 80850011833762 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033108-100
In Commercial Distribution
- 10850011833756 ()
- 00850011833759 ()
- 80850011833755 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7053008-100
In Commercial Distribution
- 10850011833565 ()
- 00850011833568 ()
- 80850011833564 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7033108-100
In Commercial Distribution
- 10850011833558 ()
- 00850011833551 ()
- 80850011833557 ()
- Insulin syringe/needle, basic
The Advantage Pole is a high quality, commercial grade floor mounted support pole. The Advantage Pole is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Pole mast is installed to a structural floor. The maximum user weight is 450lbs / 205kgs. Note: Product is not intended to support full body weight.
Healthcraft Products Inc.
AR-AP-HD
In Commercial Distribution
- 00689281000482 ()
0048
- Freestanding support rail
Geo 3D Analog is a structure that is connected to the impression coping after the impression body is removed from the oral cavity, and is inserted into the dental plaster model. It is used to accurately replicate the location and dimensions of the fixture placed in the oral cavity during prosthesis fabrication, acting as a substitute for the actual fixture.
GEOMEDI INC.
3D-SURO
In Commercial Distribution
- 08800028704681 ()
- Dental implant analog
Geo 3D Analog is a structure that is connected to the impression coping after the impression body is removed from the oral cavity, and is inserted into the dental plaster model. It is used to accurately replicate the location and dimensions of the fixture placed in the oral cavity during prosthesis fabrication, acting as a substitute for the actual fixture.
GEOMEDI INC.
3D-SUM
In Commercial Distribution
- 08800028704674 ()
- Dental implant analog
Geo 3D Analog is a structure that is connected to the impression coping after the impression body is removed from the oral cavity, and is inserted into the dental plaster model. It is used to accurately replicate the location and dimensions of the fixture placed in the oral cavity during prosthesis fabrication, acting as a substitute for the actual fixture.
GEOMEDI INC.
3D-DER
In Commercial Distribution
- 08800028704537 ()
- Dental implant analog
The QWIX positioning screw is a cannulated screw of 7.5mm diameters. It is fully threaded and has a self-tapping tip. The screw is cannulated to enable the use of a K-Wire for an optimal positioning (2.5mm K-Wire for the 7.5mm screws). It is made from titanium alloy with anodic oxidation, and color coded according to the different diameters. It is delivered sterile.
NEWDEAL
121820SND
In Commercial Distribution
- 10381780048145 ()
- M248121820SND1 ()
- 7.5mm diam. x 120mm length
121820SND
- Orthopaedic bone screw, non-bioabsorbable, sterile