Skinvive 98307

GUDID 30840228300060

Skinvive 2 x 1.0 mL

Allergan, Inc.

Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 30840228300060
• NIH Device Record Key: 3353cf24-48ab-4f5b-9f61-2399e32240da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Skinvive
• Version Model Number: 98307
• Catalog Number: 98307
• Company DUNS: 144796497
• Company Name: Allergan, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com
• Phone: 8773455372
• Email: Aus-psreporting@allergan.com

Device Dimensions

• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge
• Needle Gauge: 32 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840228300066 [Primary]
GS1	30840228300060 [Package]; Contains: 10840228300066; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110033

FDA Product Code

• LMH: Implant, Dermal, For Aesthetic Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-30
• Device Publish Date: 2023-05-22

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