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A sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Nuvagen Collagen Powder is a hydrophilic, hydrocolloid wound-powder with a collagen base. It is an insoluble fibrous type I bovine derived from cowhide.
Cpn Biosciences, LLC
2002
In Commercial Distribution
- 00618474000510 ()
2002
- Animal-derived wound matrix dressing
Restrata(R) is a sterile, single use device intended for use in local management of wounds. Restrata(R) is a soft, white, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur.
Acera Surgical Inc
RWM1-1X2
In Commercial Distribution
- 00854258006129 ()
- Length: 5.0 Centimeter
- Width: 2.5 Centimeter
- Bioabsorbable wound dressing
MPM Triple Helix Collagen Wound Drsg 7X7 Sterile. is an advance wound care device 100% bovine type 1 collagen. MPM collagen is a biogradable pad to absorbe exudate Package configuration: 1 dressing per SBS; 10 SBS per case
Mpm Medical, LLC
2
In Commercial Distribution
- 00366977377775 ()
MP00377
- Animal-derived wound matrix dressing
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution
- B553TEMPOINSIGHTS110 ()
- Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution
- B553TEMPOINSIGHTS100 ()
- Home pharmaceutical management support software
BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services
Forward Science Technologies LLC
BioStom 10ct
In Commercial Distribution
- 00370275850502 ()
- General oral wound dressing, non-animal-derived
BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services.
Forward Science Technologies LLC
BioStom 25ct
In Commercial Distribution
- 00370275850250 ()
- General oral wound dressing, non-animal-derived
BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services
Forward Science Technologies LLC
BioStom 1ct
In Commercial Distribution
- 00370275850106 ()
- General oral wound dressing, non-animal-derived
The NSS Neurostim ((510)K140530) 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 weighing approximately 5 grams 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.
KEY ELECTRONICS, INC.
Neurostim
In Commercial Distribution
- B327NSS201 ()
- B327NSS2012 ()
- B327NSS2011 ()
01-1021
- Acupuncture electrical stimulation system
HemCon ChitoGauze®XR PRO is a haemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution
- 50870053000013 ()
- 00870053000018 ()
1089
- Chitosan haemostatic agent, professional, non-bioabsorbable