FDA.reportPublic FDA data

Dyonics Drill

Primary DI
00885556570029
Brand
Dyonics Drill
Company
Smith & Nephew, Inc.
Model
7209391F
Catalog number
7209391F
Device description
RFB DYONICS PWR HIGH SPEED DRILL
Published
2016-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HABSAW, POWERED, AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HABSaw, Powered, And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556570029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556570029008855565700298855565700290885556570029

GMDN Terms#

Term, Definition table
TermDefinition
Line-powered surgical power tool system motorA compact line-powered engine (that may include a rechargeable battery) intended to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures that include drilling, sawing, and inserting involving bones and tough tissues (e.g., cartilage, ligaments). It may be available in two different forms: 1) a pistol-like handpiece that connects to a variety of surgical power tool attachments; or 2) a proximal attachment (e.g., micro-motor) to a variety of motorless handpieces. The device may be cannulated to permit use of a guidewire. It may be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795128737Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.HAB2026-01-29
00889795110879APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118400APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118417APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118424APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118431APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118448APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118455APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795128720Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.HAB2026-01-28
10653405990734Hall® Titan™Conmed CorporationHAB2025-12-29
10653405990741Hall® Titan™Conmed CorporationHAB2025-12-29
00885556887165PLATINUMSmith & Nephew, Inc.HAB2024-05-17
00840124510326LapiLockFUSION ORTHOPEDICS, LLCHAB2023-11-01
00840124510333LapiLockFUSION ORTHOPEDICS, LLCHAB2023-11-01
00889795131041FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131058FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131065FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131072FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131089FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131096FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131102FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131119FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131126FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131133FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131140FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131157FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131164FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131171FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131188FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131195FJ2000 SystemPARAGON 28, INC.HAB2023-10-25