Irrigation Syringe Attachment

FDA UDI

Class I (US FDA UDI)

by Biorep Technologies, Inc.

Identity

Trade Name: Irrigation Syringe Attachment FDA UDI
Generic Name: Irrigation syringe FDA UDI
Device Name: The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings FDA UDI
Model / Reference: 1.0 FDA UDI
Description: The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings FDA UDI

Identifiers

Catalog Number: ISA-001 FDA UDI
Primary DI / UDI-DI: 00861361000234 FDA UDI
FDA Product Code: KYZ FDA UDI
GMDN Term: Irrigation syringe FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6960 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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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

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Expiration Date

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Manufacturing Date

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MRI Safety

MR Conditional FDA UDI

Category: Irrigation syringe

Irrigation Syringe Attachment by Biorep Technologies, Inc. — 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: Biorep Technologies, Inc.

Sources (1)

FDA UDI 2aef0a1e-ead2-4552-8585-d9a402873841 35 fields · synced May 30, 2026