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Rolyan 081301654

by Performance Health Supply, LLC United States GUDID

Product code MDA

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885914040485 UDI-DIDate20 Mar 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

GUDID · synced 22 Oct 2026

Trade Name
Rolyan
Generic Name
Scar-management dressing, reusable
Model / Ref / Catalog
081301654, N/A
Primary DI / UDI-DI
00885914040485
510(k) Number
FDA Product Code
MDA
GMDN Term
Scar-management dressing, reusable
Device Class
Class I
Regulation Number
878.4025
Commercial Distribution
In Commercial Distribution

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (1)

  • FDA UDI 9e137eb2-61c6-4b2c-8e6d-7e50fb2102c8 35 fields · synced 22 Oct 2026