FDA.reportPublic FDA data

Strauss Surgical

Primary DI
00851925007199
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-4032-300N
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083553000NASO-LARYNGO-PHARYNGOSCOPESchoelly Imaging, Inc.2009-01-16EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851925007199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851925007199008519250071998519250071990851925007199

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic nasopharyngolaryngoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the structures inside the nasal passages, including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords. It is inserted through a nostril and typically provides the operator with greater manoeuvrability (flexibility of the distal end) for improved viewing during nasopharyngolaryngoscopy. Anatomical images are transmitted to the user by the device through 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
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
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04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925948VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
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04580826926006VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
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04961333255528PENTAX MedicalHOYA CORPORATIONEOB2026-08-25
04961333256181PENTAXHOYA CORPORATIONEOB2026-08-25
07613327631395N/ASTRYKER CORPORATIONEOB2026-06-19
07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16