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The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, Large)
In Commercial Distribution
- 00850012035428 ()
KO4552R-L
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, Medium)
In Commercial Distribution
- 00850012035411 ()
KO4552R-M
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left, XLarge)
In Commercial Distribution
- 00850012035404 ()
KO4552L-XL
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left, Large)
In Commercial Distribution
- 00850012035398 ()
KO4552L-L
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left, Medium)
In Commercial Distribution
- 00850012035381 ()
KO4552L-M
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, Small)
In Commercial Distribution
- 00850012035374 ()
KO4552R-S
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left,Small)
In Commercial Distribution
- 00850012035367 ()
KO4552L-S
- Knee support orthosis
The Unite Medical® suspension sleeve is worn in conjunction with a knee orthosis to help suspend brace and prevent knee orthosis from migrating.
Unite Medical, LLC
Suspension Sleeve (Universal)
In Commercial Distribution
- 00850012035329 ()
SS2397
- Orthosis suspension unit
The Unite Medical® Cryo Pneumatic Shoulder orthosis combines pneumatic compression with cold therapy in a universal design. Indicated for post-op application or as an adjuct to a physical therapy regime, the Cryo Pneumatic Shoulder orthosis offers a wide variety of treatment options. Aids in the reduction of swelling, reduced muscle spasms, and pain relief.
Unite Medical, LLC
Cryo Pneumatic Shoulder - Universal
In Commercial Distribution
- 00850012035312 ()
Cyro3670
- Hot/cold therapy pack, reusable
- Shoulder immobilizer/orthosis, reusable
The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A single lateral upright design in conjunction with flex-hinge to unload the medial compartment of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Single Upright Knee Orthosis (Right, Universal)
In Commercial Distribution
- 00850012035251 ()
KO4351R
- Knee support orthosis
The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A single lateral upright design in conjunction with flex-hinge to unload the medial compartment of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Single Upright Knee Orthosis (Left, Universal)
In Commercial Distribution
- 00850012035244 ()
KO4351L
- Knee support orthosis
The Unite Medical® Deluxe Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.
Unite Medical, LLC
Deluxe Universal ROM Knee Brace
In Commercial Distribution
- 00850012035138 ()
KO3233-1
- Knee support orthosis
The Unite Medical® Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.
Unite Medical, LLC
Universal ROM Knee Brace
In Commercial Distribution
- 00850012035121 ()
KO3233
- Knee support orthosis
No Description
BG MEDICAL, LLC
T5050
In Commercial Distribution
- 00850011929292 ()
- 10850011929299 ()
T5050
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
T4040
In Commercial Distribution
- 00850011929278 ()
- 00850011929285 ()
T4040
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
T1418-8XD
In Commercial Distribution
- 00850011929247 ()
- 10850011929244 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
T1116-8XD
In Commercial Distribution
- 00850011929230 ()
- 10850011929237 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
T1115-8
In Commercial Distribution
- 00850011929223 ()
- 10850011929220 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
TEL613-8
In Commercial Distribution
- 00850011929216 ()
- 10850011929213 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
T613-8S
In Commercial Distribution
- 00850011929209 ()
- 10850011929206 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
TEALFIL-8
In Commercial Distribution
- 00850011929193 ()
- 10850011929190 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
T3030
In Commercial Distribution
- 00850011929186 ()
- 10850011929183 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
T221510
In Commercial Distribution
- 00850011929179 ()
- 10850011929176 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
T1415
In Commercial Distribution
- 00850011929155 ()
- 10850011929152 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
T1015
In Commercial Distribution
- 00850011929148 ()
- 10850011929145 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
T510
In Commercial Distribution
- 00850011929131 ()
- 10850011929138 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra OK-1522
In Commercial Distribution
- 00850011929124 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra OK-1015
In Commercial Distribution
- 00850011929117 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra CK-10
In Commercial Distribution
- 00850011929100 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra CK-7
In Commercial Distribution
- 00850011929094 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra O-2636
In Commercial Distribution
- 00850011929070 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra E-3030
In Commercial Distribution
- 00850011929063 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra E-2226
In Commercial Distribution
- 00850011929056 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra E-1522
In Commercial Distribution
- 00850011929049 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra R-1415
In Commercial Distribution
- 00850011929032 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra C-15
In Commercial Distribution
- 00850011929025 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra C-12
In Commercial Distribution
- 00850011929018 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
No Description
BG MEDICAL, LLC
Tintra C-10
In Commercial Distribution
- 00850011929001 ()
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
The Sharps container is single-use, disposable, non-sterile containers intended to be used for health- care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.
Promisemed Medical Devices Inc.
SSC-005
In Commercial Distribution
- 00850011833940 ()
- Sharps container
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-7103106-100
In Commercial Distribution
- 10850011833831 ()
- 00850011833834 ()
- 80850011833830 ()
- 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-8033106-100
In Commercial Distribution
- 10850011833824 ()
- 00850011833827 ()
- 80850011833823 ()
- 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-8103108-100
In Commercial Distribution
- 10850011833794 ()
- 00850011833797 ()
- 80850011833793 ()
- 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-8102912-100
In Commercial Distribution
- 10850011833787 ()
- 00850011833780 ()
- 80850011833786 ()
- 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-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
Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare
provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-32G
In Commercial Distribution
- 10850011833732 ()
- 00850011833735 ()
- 80850011833731 ()
- Blood lancet, single-use
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
NPN-32-04
In Commercial Distribution
- 10850011833695 ()
- 00850011833698 ()
- 80850011833694 ()
- Autoinjector needle
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
NPN-31-08
In Commercial Distribution
- 80850011833687 ()
- 00850011833681 ()
- Autoinjector needle
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
NPN-31-06
In Commercial Distribution
- 10850011833671 ()
- 00850011833674 ()
- 80850011833670 ()
- Autoinjector needle