FDA.reportPublic FDA data

NA

Primary DI
04055207023396
Brand
NA
Company
Richard Wolf GmbH
Model
8968015
Catalog number
8968.015
Device description
DILATOR 15FR for One-Step - Bougie application, TL 320mm, cannulated, reusable
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFLDISLODGER, STONE, BASKET, URETERAL, METAL
KOEDilator, urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFLDislodger, Stone, Basket, Ureteral, MetalGastroenterology, Urology2
KOEDilator, UrethralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207023396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207023396040552070233964055207023396

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
Lumen/Inner Diameter5Millimeter

Sterilization Methods#

Method table
Method
Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide
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
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29
04055207038529RIWO880288.022026-05-29
04055207038536RIWO880488.042026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2026-05-20
10810068811091MONARCH™ Stone Retrieval BasketAuris Health, Inc.FFL2026-05-04
00810116023721Dornier MedTech DORNIER MEDTECH AMERICA, INC.FFL2026-04-21
00810116023738Dornier MedTech DORNIER MEDTECH AMERICA, INC.FFL2026-04-21
00810116023745Dornier MedTech DORNIER MEDTECH AMERICA, INC.FFL2026-04-21
10840217910009Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
20840217910006Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00840217910002Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
03600040955468DormiaColoplast A/SFFL2024-04-05
03600040955529DormiaColoplast A/SFFL2024-04-05
03600040955581DormiaColoplast A/SFFL2024-04-05
03600040955642Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955703Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955734Dormia N.StoneColoplast A/SFFL2024-04-05
03600040326817Dormia DualPercColoplast A/SFFL2023-03-14
03600040326848Dormia DualPercColoplast A/SFFL2023-03-14
B0325561300Halo TrinitySACRED HEART MEDICAL,INC.FFL2022-12-22
B937DOF1510Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
B937DOF1580Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
B937DOF2010Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
B937DOF2080Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
00856877002650QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2021-01-27
00812261012988Meatal Dilator AdultALLWIN MEDICAL DEVICES, INC.KOE2020-09-17
00812261012995Meatal Dilator Pediatric ALLWIN MEDICAL DEVICES, INC.KOE2020-09-17
00856877002445Encore 40 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2020-07-23
00856877002636SIS MEDICAL 40atm Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2020-05-08
00856877002643SIS MEDICAL 55atm Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2020-05-08
00856877002629QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2020-03-30
00810116021383Dornier MedTechDORNIER MEDTECH AMERICA, INC.KOE2020-02-25