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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
Polyester suture, non-bioabsorbable, multifilament FDA UDI
Device Name
3-0 Braided Polyester Suture Loop with Magnet (Pouched) FDA UDI
Model / Reference
ES4-8000 FDA UDI
Description
3-0 Braided Polyester Suture Loop with Magnet (Pouched) FDA UDI

Identifiers

Catalog Number
ES4-8000, S4-8000 FDA UDI
Primary DI / UDI-DI
00842071148935 FDA UDI
510(k) Number
K241111 FDA UDI
FDA Product Code
GCJ FDA UDI
GAT FDA UDI
KGC FDA UDI
GMDN Term
Polyester suture, non-bioabsorbable, multifilament 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

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Polyester suture, non-bioabsorbable, multifilament

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

Similar devices

Also classified as Polyester suture, non-bioabsorbable, multifilament.

Cleared under the same submission

K241111 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Medical Technology, Inc.

Sources (1)

  • FDA UDI 4f331b96-28d7-42ec-92ec-d620b0610ce6 36 fields · synced Jun 9, 2026