FDA.reportPublic FDA data

JUVEDERM ULTRA

Primary DI
10888628044746
Brand
JUVEDERM ULTRA
Company
Allergan, Inc.
Model
96206
Catalog number
96206
Device description
Juvéderm ULTRA 2x0.55mL
Published
2019-04-22
Public version status
Update
Distribution status
Not 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
LMHImplant, Dermal, For Aesthetic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMHImplant, Dermal, For Aesthetic UseUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P050047066

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050047066JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTSAllergan2006-06-02LMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888628044739PackageGS12Not in Commercial Distribution
10888628044746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088862804473910888628044739
1088862804474610888628044746

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
8773455372aus-psreporting@allergan.com

Regulatory Flags#

DUNS number
144796497
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
00888628047474XEN Glaucoma Treatment System5513-0015513-0012026-07-17
10888628031432Natrelle Inspira ST Resterilizable SizersMSZST-L110MSZST-L1102016-10-04
10888628031449Natrelle Inspira ST Resterilizable SizersMSZST-L125MSZST-L1252016-10-04
10888628031456Natrelle Inspira ST Resterilizable SizersMSZST-L140MSZST-L1402016-10-04
10888628031463Natrelle Inspira ST Resterilizable SizersMSZST-L170MSZST-L1702016-10-04
10888628031470Natrelle Inspira ST Resterilizable SizersMSZST-L200MSZST-L2002016-10-04
10888628031487Natrelle Inspira ST Resterilizable SizersMSZST-L230MSZST-L2302016-10-04
10888628031494Natrelle Inspira ST Resterilizable SizersMSZST-L260MSZST-L2602016-10-04
10888628031500Natrelle Inspira ST Resterilizable SizersMSZST-L290MSZST-L2902016-10-04
10888628031517Natrelle Inspira ST Resterilizable SizersMSZST-L320MSZST-L3202016-10-04
10888628031524Natrelle Inspira ST Resterilizable SizersMSZST-L350MSZST-L3502016-10-04
10888628031531Natrelle Inspira ST Resterilizable SizersMSZST-L380MSZST-L3802016-10-05
10888628031548Natrelle Inspira ST Resterilizable SizersMSZST-L410MSZST-L4102016-10-05
10888628031555Natrelle Inspira ST Resterilizable SizersMSZST-L460MSZST-L4602016-10-05
10888628031562Natrelle Inspira ST Resterilizable SizersMSZST-L510MSZST-L5102016-10-05
10888628031579Natrelle Inspira ST Resterilizable SizersMSZST-L560MSZST-L5602016-10-05
10888628031586Natrelle Inspira ST Resterilizable SizersMSZST-L610MSZST-L6102017-03-20
10888628031593Natrelle Inspira ST Resterilizable SizersMSZST-LP125MSZST-LP1252016-10-05
10888628031609Natrelle Inspira ST Resterilizable SizersMSZST-LP145MSZST-LP1452016-10-05
10888628031616Natrelle Inspira ST Resterilizable SizersMSZST-LP165MSZST-LP1652016-10-05

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08057607270086RadiesseNUVARA SRLLMH2026-10-15
08057607270093Restylane LidoNUVARA SRLLMH2026-10-15
08057607270109Restylane LyftNUVARA SRLLMH2026-10-15
08057607270116Restylane RefyneNUVARA SRLLMH2026-10-15
08057607270123Restylane KysseNUVARA SRLLMH2026-10-15
08057607270130Restylane DefyneNUVARA SRLLMH2026-10-15
08057607270147SculptraNUVARA SRLLMH2026-10-15
07640123792982Belotero Volume (+) LidocaineANTEIS SALMH2026-08-08
07640123792999Belotero Volume (+) LidocaineANTEIS SALMH2026-08-08
04262487270222Radiesse (+) LidocainePharmamondis GmbHLMH2026-06-24
04262533320055JuvedermArcera GmbHLMH2026-05-08
04262533320062RestylaneArcera GmbHLMH2026-05-08
07331689120301Restylane Lyft with LidocaineQ-Med ABLMH2026-04-30
07331689120318Restylane Lyft with LidocaineQ-Med ABLMH2026-04-30
07331689120325Restylane EyelightQ-Med ABLMH2026-04-30
07331689120332Restylane EyelightQ-Med ABLMH2026-04-30
07331689120288Restylane-LQ-Med ABLMH2026-04-29
07331689120295Restylane-LQ-Med ABLMH2026-04-29
08437027710117SCULPTRASAIMA GLOBAL FARMA S.L.LMH2026-02-19
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07640173236283RHA® Dynamic VolumeTeoxane SALMH2025-12-18
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