FDA.reportPublic FDA data

ATERA

Primary DI
10817417022177
Brand
ATERA
Company
ASEPTICO, INC.
Model
FUE-100
Device description
FUE System
Published
2022-12-07
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
10817417022177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081741702217710817417022177

GMDN Terms#

Term, Definition table
TermDefinition
Hair extraction punchA hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract small plugs of donor skin containing hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
016853348
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817417021347Treace PercuplastyAA-1070TRE-TRAY2026-04-13
10817417020227AsepticoAEU-27DTCR2026-04-08
10817417020326AsepticoAEU-27DTCR-W2026-04-08
10817417021323AsepticoAE-24DIS-102026-04-08
10817417021330AsepticoAE-24DIS2026-04-08
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
10817417020210AsepticoALU-40MOM-S2023-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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