FDA.reportPublic FDA data

NA

Primary DI
04055207019894
Brand
NA
Company
Richard Wolf GmbH
Model
8693961
Catalog number
8693.961
Device description
SCALPEL 9FR CERAMIC SEMICIRCULAR resectoscope for newborns and small children, telescope Ø 1.9mm, cutting position 6 O'clock, for cutting urethral strictures, 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
EZOUrethrotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZOUrethrotomeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207019894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207019894040552070198944055207019894

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, reusableA hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3Millimeter

Sterilization Methods#

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

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
DM 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
04048551232378n.a.Karl Storz GmbH & Co. KGEZO2025-08-11
04048551232781n.a.Karl Storz GmbH & Co. KGEZO2025-08-11
00810143891263Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2024-09-27
00810143890914Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2024-04-15
00850033250756Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250886Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250893Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250909Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250916Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250923Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00190776156718MillenniumAvalign Technologies, Inc.EZO2020-11-25
00848657076494AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EZO2019-06-14
00848657085083AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EZO2019-06-14
00842331119019Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119026Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119033Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119040Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119057Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119064Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
04046826063023MediconMedicon eG. Chirurgiemechaniker-GenossenschaftEZO2018-11-13
04046826063030MediconMedicon eG. Chirurgiemechaniker-GenossenschaftEZO2018-11-13
04046826063047MediconMedicon eG. Chirurgiemechaniker-GenossenschaftEZO2018-11-13
04048551233986n.a.Karl Storz GmbH & Co. KGEZO2018-09-04
04059082029757Urethrotomy sheathSOPRO-COMEG GmbHEZO2018-03-20
04059082029764ObturatorSOPRO-COMEG GmbHEZO2018-03-20
04059082029771Urethrotomy tubeSOPRO-COMEG GmbHEZO2018-03-20
04059082029788Urethrotomy bridgeSOPRO-COMEG GmbHEZO2018-03-20
04059082029795Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029801Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029818Urethrotomy sheathSOPRO-COMEG GmbHEZO2018-03-20