FDA.reportPublic FDA data

PERFORMANCE HEALTH

Primary DI
00840216112025
Brand
PERFORMANCE HEALTH
Company
Asp Global, LLC
Model
566110
Device description
"Rolyan Buddy Straps, 2"" (5.1 cm) wide 10/PK"
Published
2022-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IPMCover, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216112025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216112025008402161120258402161120250840216112025

GMDN Terms#

Term, Definition table
TermDefinition
Splint padding/strapping materialA sheet of flexible multi-layered material intended to be used to pad or strap a splint to an appendage, typically for use on a paediatric patient. It is made of layers of cotton, nylon and non-latex rubber (e.g., neoprene) and can be cut to a required size. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09
00840216118171ASP MEDICAL1207BG22022-05-09
00840216118188ASP MEDICAL1208BG22022-05-09
00840216118195ASP MEDICAL1206BG2B2022-05-09
00840216119444ASP MEDICAL1210BG22022-05-09
00840216105423ASP MEDICALRGPA6102022-09-19
00840216102705ASP MEDICALRGPA610SL2022-08-23
00840216102644ASP MEDICALHIA1022022-08-15
00840216106659ASP MEDICALHIA4112022-08-15
00840216119291ASP MEDICALINFHW-ASP2022-08-15
00840216119505ASP MEDICALINFHWD-ASP2022-08-15
00840216101821ASP MEDICALIWA012022-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257044988MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046197MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046203MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046210MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046463MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046470MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046487MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046494MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046500MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046517MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046524MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046531MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046548MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046555MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046562MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046579MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046586MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046593MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046609MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046616MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046623MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046630MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046647MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046654MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046661MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046678MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046685MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046692MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046708MEDIMEDI MANUFACTURING, INC.IPM2025-10-03
00636257046715MEDIMEDI MANUFACTURING, INC.IPM2025-10-03