FDA.report

aScope™ 4 Cysto

Primary DI
05707480157723
Brand
aScope™ 4 Cysto
Company
Ambu A/S
Model
601101000
Catalog number
601101000
Device description
aScope 4 Cysto - Standard Deflection
Published
2023-03-08
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

Related Records

Contact Domains

Product Codes

CodeName
FAJCystoscope and accessories, flexible/rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480157716PackageGS15In Commercial Distribution
05707480157723PackageGS14In Commercial Distribution
05707480157709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480157716057074801577165707480157716
05707480157723057074801577235707480157723
05707480157709057074801577095707480157709

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length390Millimeter
Outer Diameter6Millimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
305682023
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05707480006397Perfit Collar™0002642010002642012022-12-08
05707480006403Perfit Collar™0002642020002642022022-12-08
05707480006410Perfit Collar™0002642030002642032022-12-08
05707480006427Perfit Collar™0002642040002642042022-12-08
05707480006434Perfit Collar™0002642050002642052022-12-08
05707480006441Perfit Collar™0002642060002642062022-12-08
05707480006458Perfit Collar™0002645010002645012022-12-08
05707480006465Perfit Collar™0002645020002645022022-12-08
05707480006472Perfit Collar™0002645030002645032022-12-08
05707480006489Perfit Collar™0002645040002645042022-12-08
05707480006496Perfit Collar™0002645050002645052022-12-08
05707480018420Perfit ACE™0002810000002810002022-12-08
05707480018437Military Perfit ACE™000281000MIL000281000MIL2022-12-08
05707480006526Mini Perfit ACE™0002811060002811062022-12-08
05707480025459AuraOnce321100000U321100000U2022-12-08
05707480025473AuraOnce321200000U321200000U2022-12-08
05707480025497AuraOnce321300000U321300000U2022-12-08
05707480025503AuraOnce321400000U321400000U2022-12-08
05707480025435AuraOnce321500000U321500000U2022-12-08
05707480025527AuraOnce321600000U321600000U2022-12-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00848657023122AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657023139AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657068956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069236AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069243AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069250AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657069618AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657074889AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075060AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075084AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075244AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657075725AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657076289AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657076692AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078160AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078177AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078184AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657078191AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657086936AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00848657086943AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-23
00810116023431Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-01-22
06971176281729EviewZhuhai Pusen Medical Technology Co, LtdFAJ2026-01-22
06971176281965EviewZhuhai Pusen Medical Technology Co, LtdFAJ2026-01-22
06971176283570Foot Switch (HRF-M5 PS)Zhuhai Pusen Medical Technology Co, LtdFAJ2026-01-22
00848657076845AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-15
00848657077040AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-15
00848657078061AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-01-15
06972520302893Ascend™ Single-Use Flexible Cysto-Nephroscope HDGuangzhou Red Pine Medical Instrument Co., Ltd.FAJ2025-12-31
06972520302909Ascend™ Single-Use Flexible Cysto-Nephroscope HDGuangzhou Red Pine Medical Instrument Co., Ltd.FAJ2025-12-31
04049197177603RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAJ2025-09-22