FDA.report

Strauss Surgical

Primary DI
00850033250671
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-URO-082-90
Published
2022-08-12
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

Related Records

Product Codes

CodeName
LQCLithotriptor, Biliary Mechanical

Product Code Classifications

CodeDeviceSpecialtyClass
LQCLithotriptor, Biliary MechanicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850033250671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033250671008500332506718500332506710850033250671

GMDN Terms

TermDefinition
Rigid endoscopic stone-retrieval forceps, reusableA rigid manual device intended to be inserted through the working channel of a compatible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a very long instrument with one sliding and one stationary rod, or a sheath, whose distal ends are equipped with thin grasping claws in which the stone is seized and held for extraction. The claws are typically operated by scissors-like ring handles at the proximal end of the instrument. This is a reusable device.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
00810143890921Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.LQC2024-04-15
14953170462594Single Use Mechanical Lithotriptor VOLYMPUS MEDICAL SYSTEMS CORP.LQC2024-03-25
14953170462617Single Use Mechanical Lithotriptor VOLYMPUS MEDICAL SYSTEMS CORP.LQC2024-03-25
14953170433655Single Use BML Handle VOLYMPUS MEDICAL SYSTEMS CORP.LQC2022-09-16
00850033250664Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.LQC2022-08-12
14953170420297Single Use Mechanical Lithotriptor BML-610AOLYMPUS MEDICAL SYSTEMS CORP.LQC2021-12-17
00827002572836COOKCOOK INCORPORATEDLQC2021-05-05
14953170420280OLYMPUSOLYMPUS MEDICAL SYSTEMS CORP.LQC2019-12-10
08714729296379Trapezoid RXBOSTON SCIENTIFIC CORPORATIONLQC2016-09-24
08714729296386Trapezoid RXBOSTON SCIENTIFIC CORPORATIONLQC2016-09-24
08714729296393Trapezoid RXBOSTON SCIENTIFIC CORPORATIONLQC2016-09-24
08714729296409Trapezoid RXBOSTON SCIENTIFIC CORPORATIONLQC2016-09-24
00827002216044SoehendraCOOK INCORPORATEDLQC2016-09-24
00827002218604SoehendraCOOK INCORPORATEDLQC2016-09-24
00827002254725Conquest TTCCOOK INCORPORATEDLQC2016-09-24
00827002255180Conquest TTCCOOK INCORPORATEDLQC2016-09-24
04953170032721Basket SheathOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
14953170032742Basket WireOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
14953170032766Basket WireOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170032837Coil SheathOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170032851Tube SheathOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
14953170032872Basket WireOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170032943Coil SheathOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170032967Tube SheathOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
14953170032988Basket WireOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170033001OlympusOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170033025OlympusOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
14953170033077DISPOSABLE MECHANICAL LITHOTRIPTOROLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170033247BML HANDLEOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
14953170218344Single Use Mechanical Lithotriptor VOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21