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
00850033250428Strauss SurgicalSTS-1019-060AA2022-09-07
00850033250435Strauss SurgicalSTS-1019-060BA2022-09-07
00810143893137Strauss SurgicalSTS-URO-2430-211-SL-KV2026-07-21
00810143893144Strauss SurgicalSTS-URO-2435-20B-BP2026-07-21
00810143893151Strauss SurgicalSTS-URO-2435-30-BP2026-07-21
00810143893168Strauss SurgicalSTS-URO-2435-30-BP-PI2026-07-21
00810143893175Strauss SurgicalSTS-URO-2435-33-BP2026-07-21
00810143893182Strauss SurgicalSTS-URO-2435-36-BP2026-07-21
00810143893199Strauss SurgicalSTS-HYS-175-03-BP2026-07-21
00810143893205Strauss SurgicalSTS-HYS-175-20-BP2026-07-21
00810143893212Strauss SurgicalSTS-HYS-175-30-BP2026-07-21
00810143893229Strauss SurgicalSTS-HYS-340-002026-07-21
00810143893236Strauss SurgicalSTS-HYS-340-00-BP2026-07-21
00810143893243Strauss SurgicalSTS-HYS-340-022026-07-21
00810143893250Strauss SurgicalSTS-HYS-340-02-BP2026-07-21
00810143893267Strauss SurgicalSTS-HYS-340-032026-07-21
00810143893274Strauss SurgicalSTS-HYS-340-03-BP2026-07-21
00810143893281Strauss SurgicalSTS-HYS-340-102026-07-21
00810143893298Strauss SurgicalSTS-HYS-340-10-BP2026-07-21
00810143893304Strauss SurgicalSTS-HYS-340-202026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810238290049PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
00850088713862PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
04049047074694GimmiGimmi GmbHFFO2026-08-14
B382SD921405170Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD93415040Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD459000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460350Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460360Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467010Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467020Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467030Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467040Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467050Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD48250Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493680Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493690Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493770Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD6213120Surgical DirectSurgical Direct, Inc.FFO2026-08-03
00190776407483MillenniumAvalign Technologies, Inc.FFO2026-07-31
B382SD14174550Surgical DirectSurgical Direct, Inc.FFO2026-07-31
B382SD90712216T0Surgical DirectSurgical Direct, Inc.FFO2026-07-29
B382SD907581320Surgical DirectSurgical Direct, Inc.FFO2026-07-24
B382SD9075041030Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530128T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530129T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907573330Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9075800910Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907580150Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9076231100Surgical DirectSurgical Direct, Inc.FFO2026-07-17