Head Strap

FDA UDI

Class I (US FDA UDI)

by Enter Medical Corporation

Identity

Trade Name: HEAD STRAP FDA UDI
Generic Name: Anaesthesia mask strap, single-use FDA UDI
Device Name: HEAD STRAP FDA UDI
Model / Reference: ENT-2023 FDA UDI
Description: HEAD STRAP FDA UDI

Identifiers

Primary DI / UDI-DI: 04719872109723 FDA UDI
FDA Product Code: BTK FDA UDI
GMDN Term: Anaesthesia mask strap, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Anaesthesia mask strap, single-use

Head Strap by Enter Medical Corporation — 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: Enter Medical Corporation

Sources (1)

FDA UDI 6725b5e6-a7f7-4dc7-ade7-456ffc4b881d 33 fields · synced Jun 8, 2026