FDA.report

Duette

Primary DI
00827002340367
Brand
Duette
Company
COOK IRELAND LTD
Model
G34036
Catalog number
DT-6
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
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KNSUnit, electrosurgical, endoscopic (with or without accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002340367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002340367008270023403678270023403670827002340367

GMDN Terms

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

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

Sterilization Methods

Method

Contacts

PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags

DUNS number
988559035
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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10827002256740SolusG25674ZSS-10-9-RB2015-10-24
10827002256757SolusG25675ZSS-10-12-RB2015-10-24
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10827002256856SolusG25685ZSS-10-10-RB2015-10-24
10827002268293SolusG26829ZSS-10-1-RB2015-10-24
10827002496559Cotton-Leung Sof-FlexG49655CLSO-SF-10-92015-11-03
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10827002496580Cotton-Leung Sof-FlexG49658CLSO-SF-7-52015-11-03
10827002496597Cotton-Leung Sof-FlexG49659CLSO-SF-7-72015-11-03
10827002496610Cotton-Leung Sof-FlexG49661CLSO-SF-7-122015-11-03
10827002496627Cotton-Leung Sof-FlexG49662CLSO-SF-7-152015-11-03
10827002496658Geenen Sof-FlexG49665GPSO-SF-5-72015-11-03
10827002496665Geenen Sof-FlexG49666GPSO-SF-5-92015-11-03
10827002496672Geenen Sof-FlexG49667GPSO-SF-5-122015-11-03
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10827002496726Geenen Sof-FlexG49672GPSOS-SF-5-122015-11-03

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