GEMINI Suture Loop

FDA UDI

Class II (US FDA UDI)

by Applied Medical Technology, Inc.

Identity

Trade Name: GEMINI Suture Loop FDA UDI
Generic Name: Suturing unit, single-use FDA UDI
Device Name: GEMINI Suture Loop with Magnet Technology (Pouched) FDA UDI
Model / Reference: ES4-8000-01 FDA UDI
Description: GEMINI Suture Loop with Magnet Technology (Pouched) FDA UDI

Identifiers

Catalog Number: ES4-8000-01, S4-8000-01 FDA UDI
Primary DI / UDI-DI: 00842071147297 FDA UDI
510(k) Number: K241111 FDA UDI
FDA Product Code: GCJ FDA UDI
GAT FDA UDI
KGC FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
878.5000 FDA UDI
876.5980 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Suturing unit, single-use

GEMINI Suture Loop by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Suturing unit, single-use.

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Cleared under the same submission

K241111 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Applied Medical Technology, Inc.

Sources (1)

FDA UDI 1a99e579-26e5-4b6e-9472-2763d3924dec 36 fields · synced Jun 9, 2026