FDA.reportPublic FDA data

Rystora Scar Tape, Disposable

Primary DI
04711182607555
Brand
Rystora Scar Tape, Disposable
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
SAR251500
Published
2021-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MDAElastomer, Silicone, For Scar Management

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDAElastomer, Silicone, For Scar ManagementGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04711182607555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04711182607555047111826075554711182607555

GMDN Terms#

Term, Definition table
TermDefinition
Scar management dressing, reusableA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656763489
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14711182608306Silicone T Drainage Set With Eyes1910-82202023-10-24
14711182608313Silicone T Drainage Set With Eyes1910-82242023-10-24
04711182608163Rystora Skin Protector-SpraySY010302022-01-31
04710961934844Silicone C.W.V. Reservoir2013-06152022-01-31
04710961934851Silicone C.W.V. Reservoir2013-06202022-01-31
04710961934868Silicone C.W.V. Reservoir2013-06402022-01-31
04710961934875Silicone C.W.V. Reservoir (Top Outlet)2013-16402022-01-31
04710961934882Silicone C.W.V. Reservoir2013-09102022-01-31
04710961934899Silicone C.W.V. Reservoir2013-09152022-01-31
04710961934905Silicone C.W.V. Reservoir2013-09202022-01-31
04710961934912Silicone C.W.V. Reservoir2013-09402022-01-31
04710961934967Silicone Flat Drain2014-00522022-01-31
04710961934974Silicone Flat Drain2014-00712022-01-31
04710961934981Silicone Flat Drain2014-00722022-01-31
04710961934998Silicone Flat Drain2014-01012022-01-31
04710961935001Silicone Flat Drain2014-01022022-01-31
04710961935018Silicone Flat Drain2014-01312022-01-31
04710961935025Silicone Flat Drain2014-01322022-01-31
04710961935032Silicone Flat Drain Kit2014-90512022-01-31
04710961935049Silicone Flat Drain Kit2014-90522022-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885914040461RolyanPerformance Health Supply, LLCMDA2026-03-20
00885914040478RolyanPerformance Health Supply, LLCMDA2026-03-20
00885914040485RolyanPerformance Health Supply, LLCMDA2026-03-20
00358962230806ScarAway Silicone Scar TapeAlliance Pharma Inc.MDA2026-02-19
10850072068777CeladiaBiowound Solutions, Inc.MDA2025-12-18
10850072068784CeladiaBiowound Solutions, Inc.MDA2025-12-18
04719884330269H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-12
04719884330368H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-12
04719884333765H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-11
16972949026117SensifineHangzhou R&L Medical Device Co., LtdMDA2025-12-08
00816465020008NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020015NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020046NewGel+UV Silicone Gel for Scars + SPF30Newmedical Technology, Inc.MDA2025-08-07
00816465020213Silagen 100% Pure Silicone GelNewmedical Technology, Inc.MDA2025-08-07
00816465020220Silagen 100% Pure Silicone GelNewmedical Technology, Inc.MDA2025-08-07
00816465020237Silagen Silicone Gel for Scars + SPF30 UV ProtectionNewmedical Technology, Inc.MDA2025-08-07
00816465020244Silagen Silicone Gel for Scars + SPF30 UV ProtectionNewmedical Technology, Inc.MDA2025-08-07
00816465020299NewGel+E Advanced Silicone Gel for ScarsNewmedical Technology, Inc.MDA2025-08-07
00816465020305NewGel+E Advanced Silicone Gel for ScarsNewmedical Technology, Inc.MDA2025-08-07
00816465020329NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020336NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020343NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020350NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020367Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020374Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020381Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020398Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020404Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020411Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020572Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07