FDA.reportPublic FDA data

Strauss Surgical

Primary DI
00850033250893
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-URO-711-01
Published
2022-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EZOUrethrotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZOUrethrotomeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033250893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033250893008500332508938500332508930850033250893

GMDN Terms#

Term, Definition table
TermDefinition
UreterotomeA device passed through the biopsy port of a dedicated endoscope allowing the surgeon to make a controlled incision in the ureter. It is a long, thin, endotherapy instrument with a sharp knife-like blade at the distal end. 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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810143893311Strauss SurgicalSTS-HYS-340-20-BP2026-07-21
00810143893007Strauss SurgicalSTS-URO-100-2002026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD439190Surgical DirectSurgical Direct, Inc.EZO2026-08-03
04048551232378n.a.Karl Storz GmbH & Co. KGEZO2025-08-11
04048551232781n.a.Karl Storz GmbH & Co. KGEZO2025-08-11
00810143891263Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2024-09-27
00810143890914Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2024-04-15
00850033250756Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250886Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250909Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250916Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250923Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00190776156718MillenniumAvalign Technologies, Inc.EZO2020-11-25
00848657076494AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EZO2019-06-14
00848657085083AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EZO2019-06-14
00842331119019Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119026Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119033Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119040Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119057Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119064Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
04046826063023MediconMedicon eG. Chirurgiemechaniker-GenossenschaftEZO2018-11-13
04046826063030MediconMedicon eG. Chirurgiemechaniker-GenossenschaftEZO2018-11-13
04046826063047MediconMedicon eG. Chirurgiemechaniker-GenossenschaftEZO2018-11-13
04048551233986n.a.Karl Storz GmbH & Co. KGEZO2018-09-04
04059082029757Urethrotomy sheathSOPRO-COMEG GmbHEZO2018-03-20
04059082029764ObturatorSOPRO-COMEG GmbHEZO2018-03-20
04059082029771Urethrotomy tubeSOPRO-COMEG GmbHEZO2018-03-20
04059082029788Urethrotomy bridgeSOPRO-COMEG GmbHEZO2018-03-20
04059082029795Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029801Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029818Urethrotomy sheathSOPRO-COMEG GmbHEZO2018-03-20