FDA.reportPublic FDA data

VIVERA PHARMACEUTICALS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30150504903015050490VIVERA PHARMACEUTICALS1N2020-04-2511100 Greenstone Ave Santa Fe Springs CA US 90670
30167131863016713186Vivera Pharmaceuticals, Inc.1N2020-04-2526021 Pala Drive - St A Mission Viejo CA US 92691

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00372380000315Vivera Pharmaceuticals - A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning.949-234-6161regulatory@viverapharma.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2234261264444260K001608BLAINE SCARCARE PATCHMDA2000-07-25
2484051264444260K001608BLAINE SCARCARE PATCHMDA2000-07-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MDA22000-07-25

GUDID#

Vivera Pharmaceuticals - A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning.

VIVERA PHARMACEUTICALS, INC.

2021-09-17

Vivera Pharmaceuticals - A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning.

VIVERA PHARMACEUTICALS, INC.

2021-09-17

Vivera Pharmaceuticals, Inc - A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning.

VIVERA PHARMACEUTICALS, INC.

2022-07-01