FDA.reportPublic FDA data

Strauss Surgical

Primary DI
00810143890419
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-LAP-121-11
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
FBQTrocar, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBQTrocar, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143890419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143890419008101438904198101438904190810143890419

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reusableA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. 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
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
10849233014128Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-12-24
10849233014012Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-09-29
00849233013162Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-05-01
10849233013121Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-04-23
10849233012834Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-20
10849233012810Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-11
10849233012773Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-25
10849233012766Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-14
10849233012490Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
10849233012513Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
08964003163853Doctor NiceB. Ali ImpexFBQ2024-01-29
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00849233011144Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-20
10849233011172Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
10849233011226Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
10849233011110Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-15
08964003163075Doctor NiceB. Ali ImpexFBQ2023-11-10
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08964003163099Doctor NiceB. Ali ImpexFBQ2023-11-09