FDA.reportPublic FDA data

GenVisc 850 Sodium Hyaluronate

Primary DI
10193493000750
Brand
GenVisc 850 Sodium Hyaluronate
Company
Avanos Medical, Inc.
Model
50653-0006-01
Catalog number
50653-0006-01
Device description
GenVisc 850
Published
2024-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOZAcid, hyaluronic, intraarticular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOZAcid, Hyaluronic, IntraarticularUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140005005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140005005GENVISC 850Channel-Markers Medical, LLC2015-09-02MOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193493000750PackageGS150In Commercial Distribution
00193493000753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019349300075010193493000750
00193493000753001934930007531934930007530193493000753

GMDN Terms#

Term, Definition table
TermDefinition
Synovial fluid supplementation mediumA sterile viscous/elastic solution or gel (e.g., comprised of hyaluronic acids and their polymeric derivatives) intended to be injected into joints (particularly large, load-bearing joints such as the hip or knee) to help cushion the joint, especially in cases of endogenous synovial fluid reduced viscosity from degenerative disease.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature33.8 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651135718Halyard13571PM0062016-08-10
10680651136128Halyard13612PM0022016-08-10
10680651136135Halyard13613PM0032016-08-10
10680651136142Halyard13614PM0042016-08-10
10680651136159Halyard13615PM0052016-08-10
00193494135713ON-Q* Pain Relief System13571PM0062020-05-07
00193494136123ON-Q* Pain Relief System13612PM0022020-05-07
00193494136130ON-Q* Pain Relief System13613PM0032020-05-07
00193494136147ON-Q* Pain Relief System13614PM0042020-05-07
00193494136154ON-Q* Pain Relief System13615PM0052020-05-07
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262487270031DurolanePharmamondis GmbHMOZ2026-06-10
04262487270048MonoviscPharmamondis GmbHMOZ2026-06-10
05065026658012EuflexxaMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658050SynviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658005DurolaneMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658067EuflexxaMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658029MonoviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658036OrthoviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658043SynviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658074SynviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
08052570475131SupartzDAMBO SRLMOZ2025-11-26
M713891220750010HYMOVIS® ONE 32mg/4ml syringeFIDIA FARMACEUTICI SPAMOZ2025-11-07
M713FID075010HYMOVIS® ONE Professional Sample, 32mg/4ml syringeFIDIA FARMACEUTICI SPAMOZ2025-11-07
08052570473441EuflexxaDAMBO SRLMOZ2025-09-25
08052570473212DurolaneDAMBO SRLMOZ2025-09-25
08052570473229MonoviscDAMBO SRLMOZ2025-09-25
08052570477654EuflexxaDAMBO SRLMOZ2025-09-25
03770034301165SynviscUNIVERDERMMOZ2025-03-13
03770034301158SynviscUNIVERDERMMOZ2025-03-13
03770034301172SynviscUNIVERDERMMOZ2025-03-13
08437027710001DUROLANESAIMA GLOBAL FARMA S.L.MOZ2024-11-13
08437027710018MONOVISCSAIMA GLOBAL FARMA S.L.MOZ2024-11-13
08437027710025ORTHOVISCSAIMA GLOBAL FARMA S.L.MOZ2024-11-13
08437027710049SYNVISC ONESAIMA GLOBAL FARMA S.L.MOZ2024-11-13
08437027710056SYNVISCSAIMA GLOBAL FARMA S.L.MOZ2024-11-13
M713891220879010TRILURONFIDIA FARMACEUTICI SPAMOZ2024-05-07
00193493000753GenVisc 850 Sodium HyaluronateAvanos Medical, Inc.MOZ2024-03-06
00193493000760TriVisc Sodium HyaluronateAvanos Medical, Inc.MOZ2024-03-06
10193493000767TriVisc Sodium HyaluronateAvanos Medical, Inc.MOZ2024-03-06
M713891220724200Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mLFIDIA FARMACEUTICI SPAMOZ2023-10-16