FDA.reportPublic FDA data

Strauss Surgical

Primary DI
00810143890143
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-LAP-190-53
Published
2023-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FGMProbe And Director, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143890143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143890143008101438901438101438901430810143890143

GMDN Terms#

Term, Definition table
TermDefinition
General surgery wound probe/packerA slender, double-ended, hand-held manual surgical instrument intended to be used to explore and examine wounds, and additionally to introduce and pack gauze or dressings into the wound. It consists of a flat blunt blade at one end and a packer at the other end, with the handle formed from its middle section; it is made of metallic and/or synthetic polymer material. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
024725124
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143892963Strauss SurgicalSTS-HYS-GRA-50-40AS2025-06-05
00810143891294Strauss SurgicalSTS-NEP-420-25QL2025-04-25
00810143891300Strauss SurgicalSTS-URO-30-70-B102025-04-25
00810143891317Strauss SurgicalSTS-URO-HANDLE2025-04-25
00810143891324Strauss SurgicalSTS-NEP-420-142025-04-25
00810143891331Strauss SurgicalSTS-NEP-420-14T2025-04-25
00810143891348Strauss SurgicalSTS-NEP-420-162025-04-25
00810143891355Strauss SurgicalSTS-NEP-420-192025-04-25
00810143891362Strauss SurgicalSTS-NEP-521-2502025-04-25
00810143891379Strauss SurgicalSTS-NEP-526-2502025-04-25
00810143891386Strauss SurgicalSTS-NEP-521-2002025-04-25
00810143891393Strauss SurgicalSTS-NEP-526-2002025-04-25
00810143891409Strauss SurgicalSTS-NEP-500-092025-04-25
00810143892871Strauss SurgicalSTS-URO-SCI-70-40BLF2025-04-09
00810143892888Strauss SurgicalSTS-HYS-GRA-50-40CAS2025-04-09
00810143892895Strauss SurgicalSTS-URS-GRA-50-60CAR2025-04-09
00810143892901Strauss SurgicalSTS-URS-GRA-50-60PR2025-04-09
00851925007960Strauss SurgicalSTS-LAS-940-SBS2025-01-22
00810143892550Strauss SurgicalSTS-URS-GRA-40-60PS2024-12-03
00810143892567Strauss SurgicalSTS-URS-GRA-40-60SR2024-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896122826Barr ProbeSONTEC INSTRUMENTS, INC.FGM2026-03-10
00190776411831MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411848MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411855MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411862MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411879MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411886MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411893MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411909MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776406325MillenniumAvalign Technologies, Inc.FGM2025-07-21
G453332312160PEAK MEDICALPeak Medical Distribution Inc.FGM2025-06-17
00190776399993MillenniumAvalign Technologies, Inc.FGM2025-06-03
04049047024422GimmiGimmi GmbHFGM2025-05-06
G4533352001180PEAK MEDICALPeak Medical Distribution Inc.FGM2025-01-20
G586G91027310Novo SurgicalNOVO SURGICAL, INC.FGM2024-10-15
04049197272230RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20
04049197272247RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20
04049197272254RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20
04055207009840NARichard Wolf GmbHFGM2024-08-19
G4533343613000PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
G4533343614000PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
G4533343614120PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
G4533343614340PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
G4533343614560PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
G4533343614780PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
04049197188333RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-06-28
04049197188340RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-06-28
04049197259019RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-06-28
04049197263511RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-06-28
04049197263542RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-06-28