FDA.report

EchoTip

Primary DI
00827002240629
Brand
EchoTip
Company
COOK IRELAND LTD
Model
G24062
Catalog number
ECHO-HD-25-EBUS-O
Device description
Echotip Ultra, Endobronchial High Definition Ultrasound Needle
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
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FCGBiopsy needle

Product Code Classifications

CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002240629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002240629008270022406298270022406290827002240629

GMDN Terms

TermDefinition
Ultrasound aspiration biopsy procedure kitA collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry location, away from temperature extremes
Special Storage Condition, Specify00Store the device in a dry location

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
false
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
false
No natural rubber latex
false
Sterilization required before use
false

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10827002496658Geenen Sof-FlexG49665GPSO-SF-5-72015-11-03
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