FDA.report

n.a.

Primary DI
04048551102527
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
26183MB
Device description
SUPRALOOP Outer Sheath, 5 mm, 30 cm
Published
2018-07-21
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

Related Records

Product Codes

CodeName
KNFCOAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551102527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551102527040485511025274048551102527

GMDN Terms

TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
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 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 DIBrandCompanyProduct codePublished
30817929020368Sonata® Dispersive ElectrodeGYNESONICS, INC.KNF2021-07-07
10817929020371Sonata® Radiofrequency Ablation HandpieceGYNESONICS, INC.KNF2021-07-07
10817929020173Sonata® RFA Handpiece Cable, ReusableGYNESONICS, INC.KNF2021-07-07
10817929020166Sonata® Procedure Kit GYNESONICS, INC.KNF2020-10-07
10817929020340Sonata System SoftwareGYNESONICS, INC.KNF2020-10-07
04042761086257OlympusOLYMPUS Winter & Ibe GmbHKNF2020-07-31
04038653285013ADTEC MONOPOLARAesculap AGKNF2020-07-07
04046955308781AESCULAPAesculap AGKNF2020-06-22
04046955334551AESCULAPAesculap AGKNF2020-06-22
04046955334575AESCULAPAesculap AGKNF2020-06-22
00810116021734Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021741Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021758Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
04038653183739AESCULAPAesculap AGKNF2020-04-23
04038653284825ADTEC MONOPOLARAesculap AGKNF2020-04-23
10817929020357Sonata® System SoftwareGYNESONICS, INC.KNF2020-02-21
10817929020005Sonata® Case Kit GYNESONICS, INC.KNF2019-05-10
10381780490357MicroFrance®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKNF2018-09-14
04048551102503n.a.Karl Storz GmbH & Co. KGKNF2018-07-21
04048551094631BETTOCCHIKarl Storz GmbH & Co. KGKNF2017-10-20
04048551364864n.a.Karl Storz GmbH & Co. KGKNF2017-05-19
04048551347645n.a.Karl Storz GmbH & Co. KGKNF2016-12-22
04055207040133NARichard Wolf GmbHKNF2016-09-28
20653405035067CONMEDConmed CorporationKNF2016-09-24
20653405035098CONMEDConmed CorporationKNF2016-09-24
04046963682279AESCULAPAesculap AGKNF2016-09-24
04048551094396n.a.Karl Storz GmbH & Co. KGKNF2016-09-23
04048551393086n.a.Karl Storz GmbH & Co. KGKNF2016-09-23
04048551393567n.a.Karl Storz GmbH & Co. KGKNF2016-09-23
04048551266687n.a.Karl Storz GmbH & Co. KGKNF2016-09-23