SKIN TEST GBS0501

GUDID 10350224000032

Skin Test 0.3cc syringe

SUNEVA MEDICAL, INC.

Dermal tissue reconstructive material, animal-derived
Primary Device ID10350224000032
NIH Device Record Keyca26e21a-0bc2-4978-bb88-19f747ae5554
Commercial Distribution StatusIn Commercial Distribution
Brand NameSKIN TEST
Version Model Number0.3cc
Catalog NumberGBS0501
Company DUNS012844615
Company NameSUNEVA MEDICAL, INC.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE

Device Identifiers

Device Issuing AgencyDevice ID
GS100350224000035 [Primary]
GS110350224000032 [Package]
Contains: 00350224000035
Package: Carton [5 Units]
In Commercial Distribution
GS120350224000039 [Package]
Contains: 00350224000035
Package: Carton [2 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-27
Device Publish Date2019-03-19

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00350224000134 - Amplifine2021-01-08 Amplifine HD PRP Tube 30ml, Blood Draw kit
10350224000032 - SKIN TEST2019-03-27Skin Test 0.3cc syringe
10350224000032 - SKIN TEST2019-03-27 Skin Test 0.3cc syringe

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