FDA.reportPublic FDA data

Sutter

Primary DI
ESUM3601120
Brand
Sutter
Company
Sutter Medizintechnik GmbH
Model
360112
Catalog number
360112
Device description
Foot-switch, 2 pedals small + push button, ex. proof, 4m cable Class IPX8
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESUM3601120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497641962560info@sutter-med.de

Regulatory Flags#

DUNS number
316625425
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ESUMARS980010SutterAR-S9800-1AR-S9800-12026-08-27
ESUM3644100Sutter3644103644102026-05-22
ESUM360100050Sutter360100-05360100-052026-02-18
ESUM700925SGS0Sutter700925SGS700925SGS2026-02-17
ESUM700951SGS0Sutter700951SGS700951SGS2026-02-17
ESUM700953SGS0Sutter700953SGS700953SGS2026-02-17
ESUMARS980500350SutterAR-S9805-0035AR-S9805-00352024-01-29
ESUM700957SGS0Sutter700957SGS700957SGS2025-08-15
ESUM700958SGS0Sutter700958SGS700958SGS2025-08-15
ESUM700951S0Sutter700951S700951S2025-07-21
ESUM700907SGS0Sutter700907SGS700907SGS2025-07-03
ESUM700911SGS0Sutter700911SGS700911SGS2025-07-03
ESUM700912SGS0Sutter700912SGS700912SGS2025-07-03
ESUM700917SGS0Sutter700917SGS700917SGS2025-07-03
ESUM700919SGS0Sutter700919SGS700919SGS2025-07-03
ESUM700920SGS0Sutter700920SGS700920SGS2025-07-03
ESUM700967SGS0Sutter700967SGS700967SGS2025-07-03
ESUM700969SGS0Sutter700969SGS700969SGS2025-07-03
ESUM700987SGS0Sutter700987SGS700987SGS2025-07-03
ESUM700990SGS0Sutter700990SGS700990SGS2025-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26
00841019123928KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-22
00190776427153MillenniumAvalign Technologies, Inc.GEI2026-08-21
B382SD83042110011NS0Surgical DirectSurgical Direct, Inc.GEI2026-08-21
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426354MillenniumAvalign Technologies, Inc.GEI2026-08-18