GELSYN-3

GUDID 08033638951057

INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT

IBSA FARMACEUTICI ITALIA SRL

Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium
Primary Device ID08033638951057
NIH Device Record Key7f58a728-9b07-450d-a1b7-ee034f77e9c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameGELSYN-3
Version Model NumberGS3111
Company DUNS655395317
Company NameIBSA FARMACEUTICI ITALIA SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it
Phone1-800-836-4080
Emailinfo@ibsa.it

Device Dimensions

Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter
Total Volume2.25 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO FREEZE
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS108033638951057 [Primary]
NDC/NHRIC89130-3111-1 [Secondary]

FDA Product Code

MOZAcid, Hyaluronic, Intraarticular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-02-22
Device Publish Date2016-07-25

Trademark Results [GELSYN-3]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GELSYN-3
GELSYN-3
86888721 5125702 Live/Registered
BIOVENTUS LLC
2016-01-27
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