FDA.reportPublic FDA data

n.a.

Primary DI
04048551394373
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27068K-S
Device description
KNIFE,COLD,STERILE,STRAIGHT
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
04048551394373PrimaryGS10
04048551394380Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551394373040485513943734048551394373
04048551394380040485513943804048551394380

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315731430
Device count
6
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551232378n.a.27033U27033U2025-08-11
04048551232781n.a.27047B27047B2025-08-11
04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

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
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
04059082029825Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029832Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029849Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029856Urethrotomy sheathSOPRO-COMEG GmbHEZO2018-03-20