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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
Neurosurgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Splint Pattern Marker, 12/PK FDA UDI
Model / Reference
A37147 FDA UDI
Description
Splint Pattern Marker, 12/PK FDA UDI

Identifiers

Primary DI / UDI-DI
00840216112124 FDA UDI
FDA Product Code
ILH FDA UDI
GMDN Term
Neurosurgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Neurosurgical procedure kit, non-medicated, reusable

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

Similar devices

Also classified as Neurosurgical procedure kit, non-medicated, reusable.

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 63216c46-c044-4b0b-86e2-8d18aaeb3d2b 33 fields · synced May 30, 2026