FDA.reportPublic FDA data

Strauss Surgical

Primary DI
00851925007847
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-LAP-343-53P
Published
2023-03-08
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
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851925007847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851925007847008519250078478519250078470851925007847

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, reusableAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
024725124
Device count
1
DM exempt
false
Premarket exempt
false
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
false
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
16932503512227Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-08
16932503512210Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512234Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512241Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512258Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512265Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512272Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512289Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512296Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512302Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512319Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512326Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512333Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512340Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512357Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512364Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512371Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512388Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512395Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512401Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512418Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513187Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513194Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513200Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
14953170466349Single Use 3-Lumen Needle Knife VOLYMPUS MEDICAL SYSTEMS CORP.KNS2025-12-18
14953170466356Single Use 3-Lumen Needle Knife VOLYMPUS MEDICAL SYSTEMS CORP.KNS2025-12-18
00827002613508SureTome SWCOOK INCORPORATEDKNS2025-12-08
10827002613512SureTome SWCOOK INCORPORATEDKNS2025-12-08
10827002613529SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002607842COOKCOOK INCORPORATEDKNS2025-07-22