FDA.reportPublic FDA data

OTOPRONT

Primary DI
04260154548209
Brand
OTOPRONT
Company
Happersberger Otopront GmbH
Model
SIT 4 PLUS
Published
2023-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GBBChair, Surgical, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260154548209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260154548209042601545482094260154548209

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315858175
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260154546205OTOPRONTVARIO2026-07-08
04260154547271OTOPRONTRigid Endoscope otopront 0°2026-07-08
04260154547400OTOPRONTRigid Endoscope otopront 0°2026-07-08
04260154547417OTOPRONTRigid Endoscope otopront 30°2026-07-08
04260154547424OTOPRONTRigid Endoscope otopront 70°2026-07-08
04260154547448OTOPRONTRigid Endoscope otopront 0°2026-07-08
04260154547455OTOPRONTRigid Endoscope otopront 0°2026-07-08
04260154547462OTOPRONTRigid Endoscope otopront 30°2026-07-08
04260154547479OTOPRONTRigid Endoscope otopront 30°2026-07-08
04260154547486OTOPRONTRigid Endoscope otopront 70°2026-07-08
04260154547493OTOPRONTRigid Endoscope otopront 70°2026-07-08
04260154547530OTOPRONTRigid Endoscope otopront 30°2026-07-08
04260154540234OTOPRONTPES Eco HD2024-12-02
04260154540241OTOPRONTPES Eco HD2024-12-02
04260154540258OTOPRONTSIT MAX one2024-12-02
04260154540012OTOPRONTSMART2023-07-04
04260154541002OTOPRONTBASIC PLUS2023-07-04
04260154541019OTOPRONTBASIC PLUS2023-07-04
04260154541026OTOPRONTBASIC PLUS2023-07-04
04260154541309OTOPRONTBASIC PLUS2023-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G533BZP820KNU HealthcareKnu, LLCGBB2026-10-14
G533ZP820KNU HealthcareKnu, LLCGBB2026-10-14
06975582544188COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.GBB2026-09-18
06975582544195COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.GBB2026-09-18
M368FR601EPCHBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCHBN96071LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCHNN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCNBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCNNN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCOBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCONN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNHBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNHNN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNHNN86021LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNNBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNNBN86041LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNNNN03171LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNNNN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNOBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNONN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNONN13111LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EUCHBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EUCHNN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCHBNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCHNNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCNBNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCNNNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCOBNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCONNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPNHBNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18