FDA.reportPublic FDA data

Prosurg

Primary DI
10851545007699
Brand
Prosurg
Company
PROSURG INC
Model
NVL
Catalog number
NVL
Device description
Neoscope Video Processing Link Module
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K120766000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120766000ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)Prosurg, Inc.2012-09-11FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851545007699PackageGS11In Commercial Distribution
00851545007692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085154500769910851545007699
00851545007692008515450076928515450076920851545007692

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, single-useA sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
4084835474Ashvin@prosurg.com

Regulatory Flags#

DUNS number
188684609
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851545007715ProsurgNAR40NAR402020-05-12
00851545007722ProsurgNAN18NAN182020-05-12
00851545007814ProsurgNAN23NAN232020-05-12
10851545007712ProsurgNAR40NAR402020-05-12
10851545007729ProsurgNAN18NAN182020-05-12
10851545007811ProsurgNAN23NAN232020-05-12
08714729516750Signature Series M00688025702016-09-23
08714729520375Signature Series M00688020702016-09-23
08714729520382Signature Series M00688021502016-09-23
08714729520405Signature Series M00688021702016-09-23
08714729520412Signature Series M00688022502016-09-23
08714729520429Signature Series M00688022602016-09-23
08714729520436Signature Series M00688022702016-09-23
08714729520443Signature Series M00688023502016-09-23
08714729520450Signature Series M00688023602016-09-23
08714729520467Signature Series M00688023702016-09-23
08714729520474Signature Series M00688024502016-09-23
08714729520481Signature Series M00688024602016-09-23
08714729520498Signature seriesM00688024702016-09-23
08714729520504Signature Series M00688025502016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850023925442WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925459WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925466WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925473WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925558WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925565WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925572WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925589WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925596WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925909WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925916WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925923WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925930WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925985WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
06972084140498WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140504WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140511WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140528WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140597WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140603WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140610AptraNingbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140627AptraNingbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140665WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140672WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140689WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140696WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
00848657078450AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-22
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21