FDA.reportPublic FDA data

NA

Primary DI
03596010578884
Brand
NA
Company
Smith & Nephew, Inc.
Model
72200617S
Catalog number
72200617S
Device description
DYONICS POWERMAX ELITE HANDPIECE WITH BLADE MULTI-POSITIONING, NO HAND CONTROLS, SUCTION LEVER, 10 FT 3 M CORD SERVICE REPLACEMENT
Published
2015-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
03596010578884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010578884035960105788843596010578884

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

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