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Eight Medical

FDA UDI

Class I (US FDA UDI)

by Med Michigan Holdings Llc

Identity

Trade Name
Eight Medical FDA UDI
Generic Name
General-purpose patient temperature probe, single-use FDA UDI
Device Name
Myocardial temperature probe, 15mm needle, 8' length, 1/8" Plug FDA UDI
Model / Reference
8510 FDA UDI
Description
Myocardial temperature probe, 15mm needle, 8' length, 1/8" Plug FDA UDI

Identifiers

Catalog Number
8510 FDA UDI
Primary DI / UDI-DI
00817278012570 FDA UDI
FDA Product Code
KRI FDA UDI
GMDN Term
General-purpose patient temperature probe, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: General-purpose patient temperature probe, single-use

Eight Medical by Med Michigan Holdings Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose patient temperature probe, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Med Michigan Holdings Llc

Sources (1)

  • FDA UDI e1d141e9-f8e0-4f73-8846-79d6245b26e2 34 fields · synced May 30, 2026