Identity
- Trade Name
- DragonFly™, POWERED BY InvisiDrive™ HANDPIECE FDA UDI
- Generic Name
- Surgical power tool system handpiece, rotary, rechargeable battery-powered FDA UDI
- Device Name
- DragonFly™, POWERED BY InvisiDrive™ HANDPIECE - USED WITH 950-003 FOOTSWITCH FDA UDI
- Model / Reference
- 950-002 FDA UDI
- Description
- DragonFly™, POWERED BY InvisiDrive™ HANDPIECE - USED WITH 950-003 FOOTSWITCH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505009713 FDA UDI
- 510(k) Number
- K161376 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Surgical power tool system handpiece, rotary, rechargeable battery-powered 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
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical power tool system handpiece, rotary, rechargeable battery-powered
DragonFly™, POWERED BY InvisiDrive™ HANDPIECE by Grace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool system handpiece, rotary, rechargeable battery-powered.
- ZAGUAR — IMEDICOM CO., LTD. · Class I
- Surgical handpiece 1:1 — Nouvag AG · Class II
- ZAGUAR — IMEDICOM CO., LTD. · Class I
- ZAGUAR — IMEDICOM CO., LTD. · Class I
- ZAGUAR — IMEDICOM CO., LTD. · Class I
- ZAGUAR — IMEDICOM CO., LTD. · Class I
- ZAGUAR — IMEDICOM CO., LTD. · Class I
- ZAGUAR — IMEDICOM CO., LTD. · Class I
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™ FOOTSWITCH — Grace Medical, Inc.
- DragonFly™ STERILIZATION TRAY — Grace Medical, Inc.
- DragonFly™ SURGICAL DRILL SYSTEM POWERED BY Invisidrive™ — 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 0620c302-8455-4171-8fdd-d3e4665dd7d1 35 fields · synced May 30, 2026