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Thermasplint

FDA UDI

Class I (US FDA UDI)

by Whitehall Manufacturing Co

Identity

Trade Name
Thermasplint FDA UDI
Generic Name
Thermoplastic-moulding water bath FDA UDI
Device Name
SP-1600-D SPLINT PAN, AUSTRALIA FDA UDI
Model / Reference
SP-1600-D-220V-A FDA UDI
Description
SP-1600-D SPLINT PAN, AUSTRALIA FDA UDI

Identifiers

Catalog Number
SP-1600-D-220V-A FDA UDI
Primary DI / UDI-DI
00645724001188 FDA UDI
FDA Product Code
IRQ FDA UDI
GMDN Term
Thermoplastic-moulding water bath FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5950 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Thermoplastic-moulding water bath

Thermasplint by Whitehall Manufacturing Co — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thermoplastic-moulding water bath.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Whitehall Manufacturing Co

Sources (1)

  • FDA UDI 880c5989-3f6a-413a-8b26-8fa25c9a12d9 35 fields · synced Jun 1, 2026