FDA.reportPublic FDA data

Aseptico

Primary DI
10817417021330
Brand
Aseptico
Company
ASEPTICO, INC.
Model
AE-24DIS
Device description
TUBING SET DISPOSABLE 10 FT AEU-1000/1070 (Single)
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
10817417021330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081741702133010817417021330

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
4254873157regulatory@aseptico.com

Regulatory Flags#

DUNS number
016853348
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817417021408AsepticoADC-01-BLU2026-10-13
10817417020197Dentsply SironaAA-65BASE-DS2026-09-28
10817417021347Treace PercuplastyAA-1070TRE-TRAY2026-04-13
10817417020227AsepticoAEU-27DTCR2026-04-08
10817417020326AsepticoAEU-27DTCR-W2026-04-08
10817417021323AsepticoAE-24DIS-102026-04-08
10817417020166Dentsply SironaAEU-65-DS2022-12-08
10817417020371AsepticoAEU-1070-WAEU-10702026-04-06
10817417020388AsepticoAEU-1070-70V-W2026-04-06
10817417020418AsepticoAEU-7000E-WAEU-7000E-W2026-04-03
10817417020425AsepticoAEU-7000E-70V-WAEU-7000E-70V-W2026-04-03
10817417020432AsepticoAEU-7000L-WAEU-7000L-W2026-04-03
10817417020449AsepticoAEU-7000L-70V-WAEU-7000L-70V-W2026-04-03
10817417020395AsepticoAEU-6000-WAEU-6000-W2025-12-16
10817417020401AsepticoAEU-6000-70V-WAEU-6000-70V-W2025-12-16
10817417020456AsepticoAEU-350-WAEU-3502025-12-16
10817417020463AsepticoAEU-350S-WAEU-350S-W2025-12-16
10817417020319Treace PercuplastyAEU-1070TRE-70V2025-08-27
10817417022313AsepticoAEU-350SAEU-350S2024-09-18
10817417020203AsepticoALU-40MOM2023-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471222984De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-10-01
05051471226005De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-10-01
05051471226012De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-10-01
05051471226029De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-10-01
05051471226036De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-10-01
05430003362112WAW SLIM HANDPIECEDevroye Instruments BelgiumGEY2026-09-21
05430003362242WAW CHARGING STATIONDevroye Instruments BelgiumGEY2026-09-21
05430003362259WAW Duo FUE SystemDevroye Instruments BelgiumGEY2026-09-21
05430003362280WAW SOFTWAREDevroye Instruments BelgiumGEY2026-09-21
00889024712300Z1 POSTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
05051471225565De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-03
05051471225541De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-01
05051471223844De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471223851De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471223868De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471219519De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-24
05051471223875De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-03
05051471223639De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-01
05051471221697De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221703De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221710De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
10817417021323AsepticoASEPTICO, INC.GEY2026-04-08
10845854013144ERGOConmed CorporationGEY2026-03-24
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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