FDA.reportPublic FDA data

NA

Primary DI
04055207040881
Brand
NA
Company
Richard Wolf GmbH
Model
895506
Catalog number
8955.06
Device description
DILATOR 6FR rigid, cannulated, TL 500 mm, reusable
Published
2022-02-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOEDilator, urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOEDilator, UrethralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207040881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207040881040552070408814055207040881

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, reusableA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23
04055207013823NA80611638061.1632016-09-23
04055207013830NA80612538061.2532016-09-23
04055207013854NA80613538061.3532016-09-23
04055207013861NA80613568061.3562016-09-23
04055207013878NA80614538061.4532016-09-23
04055207013885NA80614568061.4562016-09-23
04055207013892NA80614578061.4572016-09-23
04055207013908NA80618538061.8532016-09-23
04055207013922NA80622518062.2512016-09-23
04055207013939NA80623518062.3512016-09-23
04055207013946NA80624518062.4512016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2026-05-20
06976358503538SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503545SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503552SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503569SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503576SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503583SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
10840217910009Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
20840217910006Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00840217910002Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00853095008341Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008358Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008365Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008372Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008389Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008396Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00856877002759QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002766Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002773Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
06936534328683Single Use Urethral DilatorZhejiang Chuangxiang Medical Technology Co., LTD.KOE2023-10-24
06936881102530Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136382Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136399Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136405Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136412Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136429Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136436Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136443Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12