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CoreTech

FDA UDI

Class I (US FDA UDI)

by Vive Health Llc

Identity

Trade Name
CoreTech FDA UDI
Generic Name
Cast shoe, reusable FDA UDI
Device Name
4386 Short Walker Boot (XS) FDA UDI
Model / Reference
SUP2035BLKXS FDA UDI
Description
4386 Short Walker Boot (XS) FDA UDI

Identifiers

Primary DI / UDI-DI
00810041986917 FDA UDI
FDA Product Code
ITW FDA UDI
GMDN Term
Cast shoe, 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

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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: Cast shoe, reusable

CoreTech by Vive Health Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cast shoe, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vive Health Llc

Sources (1)

  • FDA UDI ccd1f3a0-08f1-4b58-a078-ba4ed4a299f7 33 fields · synced Jun 8, 2026