FDA.reportPublic FDA data

NA

Primary DI
04055207023389
Brand
NA
Company
Richard Wolf GmbH
Model
8968012
Catalog number
8968.012
Device description
DILATOR 12FR 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
Rx
false
OTC
false
Sterile
false
Single use
false

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
04055207023389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207023389040552070233894055207023389

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 Diameter4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
DM exempt
true
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
false
Donation ID number
false
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
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
14953170458368DISPOSABLE GRASPING FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.FFL2025-05-14
00810143891300Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFL2025-04-25
00810143891317Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFL2025-04-25
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
B0325550200HaloSACRED HEART MEDICAL,INC.FFL2024-07-18
03600040955482DormiaColoplast A/SFFL2024-04-05
03600040955543DormiaColoplast A/SFFL2024-04-05
03600040955598DormiaColoplast A/SFFL2024-04-05
03600040955659Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955727Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955758Dormia N.StoneColoplast A/SFFL2024-04-05
06936534320465Single Use Urinary Stone Retrieval BasketZhejiang Chuangxiang Medical Technology Co., LTD.FFL2023-10-24
06936534328683Single Use Urethral DilatorZhejiang Chuangxiang Medical Technology Co., LTD.KOE2023-10-24
16936881102537Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136389Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136396Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136402Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136419Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136426Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136433Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136440Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12