Identity
- Trade Name
- GEMINI FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- GEMINI Suture Passer with Magnet Technology (Curved Needle, Pouched) FDA UDI
- Model / Reference
- ESD221C-07 FDA UDI
- Description
- GEMINI Suture Passer with Magnet Technology (Curved Needle, Pouched) FDA UDI
Identifiers
- Catalog Number
- ESD221C-07, SD221C-07-101, SD221C-07-105 FDA UDI
- Primary DI / UDI-DI
- 00842071144999 FDA UDI
- 510(k) Number
- K241111 FDA UDI
- FDA Product Code
- GCJ FDA UDIGAT FDA UDIKGC FDA UDI
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI878.5000 FDA UDI876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Suturing unit, single-use
Gemini by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suturing unit, single-use.
- eXact 5.1 — Cypris Medical · Class I
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- Arthrex® — Arthrex, Inc. · Class I
- OverStitch NXT Endoscopic Suturing System — Apollo Endosurgery · Class II
- SlingShot — Stryker Corp. · Class I
- NanoPass — Stryker Corp. · Class I
- DISPOSABLE NITINOL NDL SINGLE PACK — Biomet Orthopedics, Inc. · Class I
Cleared under the same submission
K241111 also covers:
- GEMINI — Applied Medical Technology, Inc.
- GEMINI — Applied Medical Technology, Inc.
- GEMINI — Applied Medical Technology, Inc.
- GEMINI Suture Loop — Applied Medical Technology, Inc.
- GEMINI Suture Loop — Applied Medical Technology, Inc.
- RHAPSO — Applied Medical Technology, Inc.
- RHAPSO — Applied Medical Technology, Inc.
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 281b27f9-13a5-4b34-a54d-e6c626a5a6e8 36 fields · synced Jun 9, 2026