FDA.reportPublic FDA data

Accessory for urology

Primary DI
04059082030746
Brand
Accessory for urology
Company
SOPRO-COMEG GmbH
Model
395 410 002
Published
2018-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FAJCystoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945262000OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESOptus, Inc.1995-05-26FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059082030746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059082030746040590820307464059082030746

GMDN Terms#

Term, Definition table
TermDefinition
Urethral bougie, reusableA rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typically has a handle at the proximal end. It may be hollow to enable passage of other slender devices. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
507185952
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059082002743Arthroscope161 191 040BC0012016-09-12
04059082002750Arthroscope161 240 980BC0012016-09-12
04059082002767Arthroscope161 240 982BC0012016-09-12
04059082002774Cystoscope161 271 140BC0012016-12-22
04059082002781Arthroscope161 271 190BC0012016-09-12
04059082002798Arthroscope161 271 192BC0012016-09-12
04059082002811Sinuscope161 271 760BC0012016-09-12
04059082002835Sinuscope161 271 762BC0012016-09-12
04059082002859Sinuscope161 271 765BC0012016-09-12
04059082002866Arthroscope161 271 770BC0012016-09-12
04059082002880Arthroscope161 271 772BC0012016-09-12
04059082002903Arthroscope161 271 775BC0012016-09-12
04059082002927Sinuscope161 271 780BC0012016-09-12
04059082002941Sinuscope161 271 782BC0012016-09-12
04059082002965Sinuscope161 271 785BC0012016-09-12
04059082003115Sinuscope161 401 800BC0012016-09-12
04059082003139Sinuscope161 401 802BC0012016-09-12
04059082003153Sinuscope161 401 803BC0012016-09-12
04059082003160Sinuscope161 401 805BC0012016-09-12
04059082003184Sinuscope161 401 810BC0012016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078450AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-22
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893144Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893151Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893168Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893175Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893182Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893199Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893205Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893212Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893229Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893236Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893243Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893250Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893267Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893274Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893281Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893298Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893304Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893311Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00848657076609AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076616AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076623AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078412AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078429AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078436AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078443AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085656AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085663AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00810143893007Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-20