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Performance Health

FDA UDI

Class I (US FDA UDI)

by Asp Global, LLC

Identity

Trade Name
PERFORMANCE HEALTH FDA UDI
Generic Name
Splint padding/strapping material FDA UDI
Device Name
Rolyan Buddy Straps, 5/8" (1.6 cm) wide 10/PK FDA UDI
Model / Reference
566108 FDA UDI
Description
Rolyan Buddy Straps, 5/8" (1.6 cm) wide 10/PK FDA UDI

Identifiers

Primary DI / UDI-DI
00840216112018 FDA UDI
FDA Product Code
IPM FDA UDI
GMDN Term
Splint padding/strapping material FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Splint padding/strapping material

Performance Health by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Splint padding/strapping material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Asp Global, LLC

Sources (1)

  • FDA UDI 464dc105-150a-407f-8e8c-f81f6cccc6e4 33 fields · synced May 30, 2026