FDA.report

NA

Primary DI
04055207044889
Brand
NA
Company
Richard Wolf GmbH
Model
8955211
Catalog number
8955.211
Device description
TELESCOPE DILATOR 21FR for nephrostomy, in particular for dilating transcutaneous punctures, TL 230mm, reusable
Published
2022-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KOEDilator, urethral

Product Code Classifications

CodeDeviceSpecialtyClass
KOEDilator, UrethralGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207044889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207044889040552070448894055207044889

GMDN Terms

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

TypeValueUnit
Outer Diameter7Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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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

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00853095008372Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008389Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
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16936881136433Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136440Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
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16936881102520Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
16936881136495Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
06936881140716Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
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08718455508270MED pro Medical B.V.MED pro Medical B.V.KOE2022-09-09