SKIN TEST GBS0501

GUDID 10350224000032

Skin Test 0.3cc syringe

SUNEVA MEDICAL, INC.

Dermal tissue reconstructive material, animal-derived

• Primary Device ID: 10350224000032
• NIH Device Record Key: ca26e21a-0bc2-4978-bb88-19f747ae5554
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKIN TEST
• Version Model Number: 0.3cc
• Catalog Number: GBS0501
• Company DUNS: 012844615
• Company Name: SUNEVA MEDICAL, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com
• Phone: 858-550-9999
• Email: customersupport@sunevamedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00350224000035 [Primary]
GS1	10350224000032 [Package]; Contains: 00350224000035; Package: Carton [5 Units]; In Commercial Distribution
GS1	20350224000039 [Package]; Contains: 00350224000035; Package: Carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020012

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: 2019-03-27
• Device Publish Date: 2019-03-19

Devices Manufactured by SUNEVA MEDICAL, INC.

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• 00350224000165 - Amplifine: 2022-02-18 Amplifine HD PRP convenience kit. Large Holder 30ml Vacutainer, 10 pack.
• 10350224000100 - Amplifine: 2021-01-08 Amplifine HD PRP tube 15ml
• 10350224000117 - Amplifine: 2021-01-08 Amplifine HD PRP Tube 30ml
• 00350224000127 - Amplifine: 2021-01-08 Amplifine HD PRP Tube 15ml, Blood Draw Kit
• 00350224000134 - Amplifine: 2021-01-08 Amplifine HD PRP Tube 30ml, Blood Draw kit
• 10350224000032 - SKIN TEST: 2019-03-27Skin Test 0.3cc syringe
• 10350224000032 - SKIN TEST: 2019-03-27 Skin Test 0.3cc syringe