Perlane

GUDID 07331689111682

Q-Med AB

Dermal tissue reconstructive material, microbe-derived
Primary Device ID07331689111682
NIH Device Record Key9e8c9980-4f8b-49ae-b613-cf8971ffd10f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerlane
Version Model NumberGel 1.0 ml syringe - demo
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107331689111682 [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 Date2014-10-10

On-Brand Devices [Perlane]

07331689111682Gel 1.0 ml syringe - demo
07331689111675Gel 1.0 ml syringe

Trademark Results [Perlane]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERLANE
PERLANE
78976443 3030752 Dead/Cancelled
NESTLÉ SKIN HEALTH S.A.
2003-03-07
PERLANE
PERLANE
78222935 3249918 Dead/Cancelled
NESTLÉ SKIN HEALTH S.A.
2003-03-07
PERLANE
PERLANE
77029489 3441344 Dead/Cancelled
HA North American Sales AB
2006-10-25
PERLANE
PERLANE
76267260 2801735 Dead/Cancelled
Q-MED AB
2001-06-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.