FDA.reportPublic FDA data

Strauss Surgical

Primary DI
00810143890259
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-LAP-305-53
Published
2023-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FFORetractor, Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143890259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143890259008101438902598101438902590810143890259

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held endoscopic retractor, reusableA hand-held manual surgical instrument intended to be used to enable retraction of tissues during endoscopic/laparoscopic surgery. It consists of a handle with a slender body connected at the distal end to a retracting mechanism (e.g., inflatable/folding paddle, fan-like spreading mechanism, retracting hook). It is intended to be introduced through a laparoscopic port or endoscopic channel; it is not intended for wound retraction or for tissue cutting. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842102116421Bookler Table Mounted Retractor SystemsFLEXBAR MACHINE CORPORATIONFFO2026-03-19
09348811023667INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-03-16
00192896122765Balfour Deluxe RetractorSONTEC INSTRUMENTS, INC.FFO2026-03-10
B382SD4942000Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942010Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942020Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942030Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942040Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942050Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942060Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942070Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942080Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942090Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942100Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942110Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942120Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942130Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942140Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942150Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942160Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942170Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942180Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942190Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942200Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942210Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD494222Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD494223Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942240Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942250Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942260Surgical DirectSurgical Direct, Inc.FFO2026-03-02