Identity
- Trade Name
- DragonFly™ ANGLED ADAPTOR-15° FDA UDI
- Generic Name
- Burring power tool attachment FDA UDI
- Device Name
- DragonFly™, POWERED BY InvisiDrive™ ANGLED ADAPTOR 15° USED WITH 950-002 HANDPIECE FDA UDI
- Model / Reference
- 950-006-15 FDA UDI
- Description
- DragonFly™, POWERED BY InvisiDrive™ ANGLED ADAPTOR 15° USED WITH 950-002 HANDPIECE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505009744 FDA UDI
- 510(k) Number
- K161376 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Burring power tool attachment 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Burring power tool attachment
DragonFly™ ANGLED ADAPTOR-15° by Grace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Burring power tool attachment.
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Cleared under the same submission
K161376 also covers:
- 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.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Grace Medical, Inc.
Sources (1)
- FDA UDI d81c28b7-d843-43d2-8dd5-e6515a984c68 35 fields · synced Jun 1, 2026