Identity
- Trade Name
- DragonFly™ FOOTSWITCH FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- DragonFly™ SURGICAL DRILL SYSTEM POWERED BY Invisidrive™ FOOTSWITCH FDA UDI
- Model / Reference
- 950-003 FDA UDI
- Description
- DragonFly™ SURGICAL DRILL SYSTEM POWERED BY Invisidrive™ FOOTSWITCH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505009737 FDA UDI
- 510(k) Number
- K161376 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foot-switch, electrical
DragonFly™ FOOTSWITCH by Grace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foot-switch, electrical.
- ElectrodeCRF — Cambridge Interventional LLC · Class IIb
- ElectrodeCRF — Cambridge Interventional LLC · Class IIb
- Alligature-E — Alan Electronic Systems Private Limited · Class IIb
- Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · U
- Arthrex® — Arthrex, Inc. · Class I
- CableAME — Cambridge Interventional LLC · Class IIb
- CORE — Stryker Corp. · Class II
- PowerPack — MICROLINE SURGICAL, INC. · Class II
Cleared under the same submission
K161376 also covers:
- DragonFly™ ANGLED ADAPTOR-15° — Grace Medical, Inc.
- DragonFly™ ANGLED ADAPTOR-25° — Grace Medical, Inc.
- DragonFly™ ANGLED ADAPTOR-35° — Grace Medical, Inc.
- DragonFly™ BATTERY SET — Grace Medical, Inc.
- DragonFly™ CHARGING SYSTEM — Grace Medical, Inc.
- DragonFly™ STERILIZATION TRAY — Grace Medical, Inc.
- DragonFly™ SURGICAL DRILL SYSTEM POWERED BY Invisidrive™ — Grace Medical, Inc.
- DragonFly™, POWERED BY InvisiDrive™ HANDPIECE — Grace Medical, 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
- Grace Medical, Inc.
Sources (1)
- FDA UDI 7e883e04-ba36-4668-b0bf-d115cb336e6f 36 fields · synced May 31, 2026