FDA.reportPublic FDA data

AED-SLT DYONICS-STOP

Primary DI
00848657069380
Brand
AED-SLT DYONICS-STOP
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
SLT-DYO
Catalog number
SLT-DYO
Device description
A hermetic seal tester for a Dyonics medical power tool
Published
2020-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657069380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657069380008486570693808486570693800848657069380

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool maintenance unitA device used for the automatic internal lubrication and maintenance of surgical power tools (e.g., pneumatically or electrically driven motors, turbines, or attachments). This device will automatically run programs for the lubrication of the internal components with service oil and flushing with compressed air after external cleansing, but prior to sterilization. This process is intended to improve performance and safety of the surgical instruments. The unit is designed to accept different handpieces which are connected directly or via adaptors to the unit's processing chamber.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
839138955
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848657078368AEDAED UH8012026-04-23
00848657078276AEDAED 33310UL-R2026-04-13
00848657078283AEDAED 33310UL2026-04-13
00848657078290AEDAED 33321A-R2026-04-13
00848657078306AEDAED 33321A2026-04-13
00848657078313AEDAED 33310FG-R2026-04-13
00848657078320AEDAED 33310FG2026-04-13
00848657078337AEDAED 33310R-R2026-04-13
00848657078344AEDAED 33310R2026-04-13
00848657078351AEDAED 34321SL2026-04-13
00848657078269AEDJZM15922026-03-02
00848657078238AED8830BL2026-02-24
00848657078245AED8830CL2026-02-24
00848657078252AED8830FL2026-02-24
00848657078214AED501.50BS2026-02-18
00848657078221AED501.51BS2026-02-18
00848657023122AEDAED11275FE2026-01-23
00848657023139AEDAED27071TJ2026-01-23
00848657068956AED2717462026-01-23
00848657069236AEDAED27071-92026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10817417021323AsepticoASEPTICO, INC.GEY2026-04-08
10817417021330AsepticoASEPTICO, INC.GEY2026-04-08
10845854013144ERGOConmed CorporationGEY2026-03-24
00193982678265VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678326VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678975VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678999VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679064VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679088VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679101VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679125VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679149VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679163VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679248VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679262VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679309VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679323VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679347VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHGEY2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHGEY2025-12-18
J021304670001S-9 ES RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2024-02-07
J021304680001S-10 RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2024-02-07
J021304700001S-12 RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2024-02-07
10845854035009ADVANTAGEConmed CorporationGEY2023-12-04
J021303870021SpeedControl SC1 (M-UK1023)W & H Dentalwerk Bürmoos GmbHGEY2023-10-12
J021303880021SpeedControl SC1 (M-UK1015)W & H Dentalwerk Bürmoos GmbHGEY2023-10-12
J021303930011M-MH40 RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2023-10-12
20845854041342CONMEDConmed CorporationGEY2023-09-01
20845854041359CONMEDConmed CorporationGEY2023-09-01
00814334022207NARichard Wolf GmbHGEY2022-12-27