FDA.reportPublic FDA data

Duette

Primary DI
00827002340541
Brand
Duette
Company
COOK IRELAND LTD
Model
G34054
Catalog number
DT-6-XL
Device description
Duette, Multi-Band Mucosectomy
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNSUnit, electrosurgical, endoscopic (with or without accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002340541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002340541008270023405418270023405410827002340541

GMDN Terms#

Term, Definition table
TermDefinition
Rigid polypectomy snare, single-useA sterile, rigid device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current. It typically consists of a rigid insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This device must be stored in a dry location, away from temperature extremes

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
988559035
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002315181EchoTipG31518ECHO-1-222016-09-24
00827002315198EchoTipG31519ECHO-252016-09-24
00827002315204EchoTipG31520ECHO-192016-09-24
00827002347854EchoTip ProCoreG34785ECHO-HD-3-20-C2016-09-24
00827002535855EchoTip ProCoreG53585ECHO-HD-19-C2016-09-24
00827002557369EchoTip ProCoreG55736ECHO-HD-22-C2016-09-24
00827002557383EchoTip ProCoreG55738ECHO-HD-25-C2016-09-24
00827002491427Fusion MarathonG49142FS-MAR-10-52015-10-24
10827002256948JohlinG25694JPWS-8.5-82015-10-24
10827002256955JohlinG25695JPWS-8.5-102015-10-24
10827002257136JohlinG25713JPWS-10-82015-10-24
10827002257143JohlinG25714JPWS-10-102015-10-24
10827002257150JohlinG25715JPWS-10-122015-10-24
10827002257167JohlinG25716JPWS-10-142015-10-24
00827002214392ZimmonG21439ZEBD-11.5-52015-10-24
00827002214422ZimmonG21442ZEBD-11.5-72015-10-24
00827002214460ZimmonG21446ZEBD-11.5-92015-10-24
00827002222076ZimmonG22207ZEBD-11.5-122015-10-24
00827002224421ZimmonG22442ZEBD-11.5-152015-10-24
10827002496658Geenen Sof-FlexG49665GPSO-SF-5-72015-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909421709CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421716CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421693CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-24
04545499074423SB Knife Jr2SB-KAWASUMI LABORATORIES, INC.KNS2026-04-06
04545499074430SB Knife Jr2 /Long typeSB-KAWASUMI LABORATORIES, INC.KNS2026-04-06
00827002613515SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002613522SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002597501Tesla BicordCOOK INCORPORATEDKNS2025-07-11
00724995226732Padlock ClipUS EndoscopyKNS2024-10-31
08809922260637ELRA ElectrodeSTARMED CO.,LTDKNS2024-08-28
04055207007822NARichard Wolf GmbHKNS2024-08-19
04055207008393NARichard Wolf GmbHKNS2024-08-19
04055207058985NARichard Wolf GmbHKNS2024-08-19
20653405051555APOLLO3Conmed CorporationKNS2024-07-22
20653405051562APOLLO3Conmed CorporationKNS2024-07-22
03665415002116Electrosurgical Unit MCBLAMIDEY NOURY MEDICALKNS2023-04-21
00851925007885Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.KNS2023-03-08
00884450329665Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502006Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502013Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502020Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450329658Brighton™Merit Medical Systems, Inc.KNS2021-06-15
00884450501993Brighton™Merit Medical Systems, Inc.KNS2021-06-15
00191506008086Axios™BOSTON SCIENTIFIC CORPORATIONKNS2021-05-27
00191506008093Axios™BOSTON SCIENTIFIC CORPORATIONKNS2021-05-27
00816207021577ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021584ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021591ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021607ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021614ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29