CHANNEL-MARKERS MEDICAL LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3042026079	3042026079	CHANNEL-MARKERS MEDICAL LLC	1	Y	2026-01-01	8801 Fast Park Dr Ste 301 Raleigh NC US 27617

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00860014587504	GenVisc® 850 - GenVisc® 850 sodium hyaluronate (P140005) is indicated for the 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. GenVisc 850 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. GenVisc 850 is supplied in a glass prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).	8444368472	info@channel-markers.com

channel-markers.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
343872	1590865909	P160057	TRIVISC	MOZ	2017-11-13
343872	1621983246	P140005	GENVISC 850	MOZ	2015-09-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MOZ	2	2017-11-13

GUDID#

GenVisc® 850 - GenVisc® 850 sodium hyaluronate (P140005) is indicated for the 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. GenVisc 850 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. GenVisc 850 is supplied in a glass prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).
Channel-Markers Medical LLC
2026-06-19