FDA.reportPublic FDA data

Strauss Surgical

Primary DI
00851925007366
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-7027-110ASA
Published
2019-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851925007366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851925007366008519250073668519250073660851925007366

GMDN Terms#

Term, Definition table
TermDefinition
Rigid sinoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
024725124
Device count
1
Serial number
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04961333255528PENTAX MedicalHOYA CORPORATIONEOB2026-08-25
04961333256181PENTAXHOYA CORPORATIONEOB2026-08-25
07613327631395N/ASTRYKER CORPORATIONEOB2026-06-19
07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16