FDA.reportPublic FDA data

ENDOFLATOR

Primary DI
04048551068793
Brand
ENDOFLATOR
Company
Karl Storz GmbH & Co. KG
Model
26430520-1
Device description
Electronic CO2 ENDOFLATOR® SCB
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
false
Single use
false

Product Codes#

Code, Name table
CodeName
HIFINSUFFLATOR, LAPAROSCOPIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551068793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551068793040485510687934048551068793

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic insufflatorA mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
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
06972304751404InflaCureSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HIF2026-05-22
16972304751555InflaCureSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HIF2026-05-22
10851885004587AIRSEALConmed CorporationHIF2026-03-21
00860012249954VereSeeFreyja Healthcare, LLCHIF2025-06-18
00860012249916VereSeeFreyja Healthcare, LLCHIF2025-06-16
G465100300AirSurgN InsufflatorSmartsurgn Inc.HIF2025-04-22
04953170467226INSUFFLATION TUBEOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-26
04953170467233SUCTION TUBEOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-26
05391536920142EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920159EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920913EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920944EVA15PALLIARE LIMITEDHIF2024-07-16
06937845500607GTKGuangzhou T.K Medical Instrument Co.,Ltd.HIF2024-05-23
06937845500614GTKGuangzhou T.K Medical Instrument Co.,Ltd.HIF2024-05-23
20845854045630AIRSEALConmed CorporationHIF2024-03-27
06973031299573Insufflation tubeGuangdong Optomedic Technologies, Inc.HIF2024-03-26
06973031299870Insufflation tubeGuangdong Optomedic Technologies, Inc.HIF2024-03-26
06973031299887InsufflatorGuangdong Optomedic Technologies, Inc.HIF2024-03-26
10886874120696NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
06971381251357InsufflatorSCIVITA MEDICAL TECHNOLOGY CO., LTD.HIF2024-02-28
06971381251364InsufflatorSCIVITA MEDICAL TECHNOLOGY CO., LTD.HIF2024-02-28
10845854045350CONMEDConmed CorporationHIF2023-12-04
10845854045398CONMEDConmed CorporationHIF2023-12-04
00810143450545MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpHIF2023-07-31
00810143450750MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpHIF2023-07-31
09420012433060Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
09420012433985Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
00850082007189Filter AssemblyARMM INC.HIF2023-06-08
00850082007196Insufflator Filter AssemblyARMM INC.HIF2023-06-08
00850082007837Insufflator Filter AssemblyARMM INC.HIF2023-06-08