Bite Block (set Of 10 Pcs)

FDA UDI

Class I (US FDA UDI)

by PaloDEx Group Oy

Identity

Trade Name: BITE BLOCK (SET OF 10 PCS) FDA UDI
Generic Name: Seizure bite block FDA UDI
Model / Reference: 203214 FDA UDI

Identifiers

Primary DI / UDI-DI: 06430035874453 FDA UDI
510(k) Number: K092591 FDA UDI
FDA Product Code: EHA FDA UDI
GMDN Term: Seizure bite block FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.1820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Seizure bite block

Bite Block (set Of 10 Pcs) by PaloDEx Group Oy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: PaloDEx Group Oy

Sources (1)

FDA UDI 69824cf7-21f4-47ad-8709-328f6dc6d791 33 fields · synced May 30, 2026