FDA.reportPublic FDA data

Strauss Surgical

Primary DI
00810143890167
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-LAP-121-91
Published
2023-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810143890167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143890167008101438901678101438901670810143890167

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143892505Strauss SurgicalSTS-LC-KO-10GR2024-08-05
00810143892512Strauss SurgicalSTS-LC-KK-10GR2024-04-08
00810143892529Strauss SurgicalSTS-LC-STR-10GR2024-04-08
00851925007700Strauss SurgicalSTS-LC-KD-10CLR2022-05-18
00851925007717Strauss SurgicalSTS-LC-KK-10CLR2022-05-18
00851925007724Strauss SurgicalSTS-LC-KK-3.8-10CLR2022-05-18
00851925007731Strauss SurgicalSTS-LC-KO-10CLR2022-05-18
00851925007748Strauss SurgicalSTS-LC-LIN-4810CLR2022-05-18
00851925007755Strauss SurgicalSTS-LC-STR-10CLR2022-05-18
00851925007762Strauss SurgicalSTS-LC-STR-3.8-10CLR2022-05-18
00851925007779Strauss SurgicalSTS-LC-XLS-4.82022-05-18
00810143891157Strauss SurgicalSTS-URO-001-16-SET2024-09-27
00810143891164Strauss SurgicalSTS-URO-001-17-SET2024-09-27
00810143891171Strauss SurgicalSTS-URO-001-19-SET2024-09-27
00810143891188Strauss SurgicalSTS-URO-001-21-SET2024-09-27
00810143891195Strauss SurgicalSTS-URO-001-23-SET2024-09-27
00810143891201Strauss SurgicalSTS-URO-001-25-SET2024-09-27
00810143890938Strauss SurgicalSTS-URO-040-252024-04-15
00810143890945Strauss SurgicalSTS-URO-001-162024-04-15
00810143890952Strauss SurgicalSTS-URO-020-162024-04-15

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Primary DI, Brand, Company table
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