Restylane Silk-L

GUDID 07331689113945

Q-Med AB

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID07331689113945
NIH Device Record Key1d94be1e-70f7-47f6-9972-95249d2ae475
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestylane Silk-L
Version Model Number1.0 ml syringe
Company DUNS355371873
Company NameQ-Med AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration not required

Device Identifiers

Device Issuing AgencyDevice ID
GS107331689113945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMHImplant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-13

On-Brand Devices [Restylane Silk-L]

073316891139521.0 ml syringe - demo
073316891139451.0 ml syringe
073316891121531.0 ml syringe - demo
073316891111701.0 ml syringe

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