JOSEPH LAMELAS Knot Pusher

FDA UDI

Class I (US FDA UDI)

by Biorep Technologies, Inc.

Identity

Trade Name: JOSEPH LAMELAS Knot Pusher FDA UDI
Generic Name: Suturing unit, single-use FDA UDI
Device Name: The JOSEPH LAMELAS Knot Pusher is a disposable surgical instrument used to advance throws of extracorporeal knots to an intracorporeal object contained within a small cavity. FDA UDI
Model / Reference: 8.0 FDA UDI
Description: The JOSEPH LAMELAS Knot Pusher is a disposable surgical instrument used to advance throws of extracorporeal knots to an intracorporeal object contained within a small cavity. FDA UDI

Identifiers

Catalog Number: MI-KP-001 FDA UDI
Primary DI / UDI-DI: 00858733006000 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.4500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Suturing unit, single-use

JOSEPH LAMELAS Knot Pusher 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 3c759280-4d1f-4e1e-b5a1-0c5615ddf51c 34 fields · synced May 29, 2026