FDA.reportPublic FDA data

Vericel

Primary DI
B504GS80210
Brand
Vericel
Company
Provision
Model
8021
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDCInstrument, Surgical, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B504GS80210PrimaryHIBCC0

Contacts#

Phone, Email table
PhoneEmail
541-508-7520customersupport@provisiondrs.com

Regulatory Flags#

DUNS number
016889401
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B504OMBMAS90006S0BrasselerBMA-S90006S2026-10-20
B504OMBMAS90007S0BrasselerBMA-S90007S2026-10-20
B504OMBMAS90008S0BrasselerBMA-S90008S2026-10-20
B504OMBMLS900040BrasselerBML-S900042026-10-20
B504OMBR2544001110BrasselerBR2544-00-1112026-10-20
B504OMBR9505023020BrasselerBR9505-02-3022026-10-20
B504OMBR9505023030BrasselerBR9505-02-3032026-10-20
B504OMDP86011710BrasselerDP86-0117-12026-10-20
B504OMST60070031000BrasselerST6007-003-1002026-10-20
B504OMST60070031500BrasselerST6007-003-1502026-10-20
B504OMST60071031100BrasselerST6007-103-1102026-10-20
B504OMST60071041500BrasselerST6007-104-1502026-10-20
B504OMZB005901020000BrasselerZB00-5901-020-002026-10-20
B504GS80200Vericel80202026-07-20
B504GS80220Vericel80222026-07-20
B504OM19S17050Brasseler19-S17052026-07-20
B504OM22963414S70Stryker2296-3-414S72026-07-20
B504OM3162880Synthes316.2882026-07-20
B504OM4058830Biomet4058832026-07-20
B504OM4058890Biomet4058892026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528297Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDC2026-07-31
00749756402699DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402705DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402750DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402767DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402781DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402798DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402910DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
B504GS80200VericelProvisionKDC2026-07-20
B504GS80220VericelProvisionKDC2026-07-20
00749756402545DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402552DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402569DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402576DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402583DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402590DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402606DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402613DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402620DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402637DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402644DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402651DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402675DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402682DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402712DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402729DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402736DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402743DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402774DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402538DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-06-26