FDA.reportPublic FDA data

EchoTip ProCore

Primary DI
00827002342811
Brand
EchoTip ProCore
Company
COOK IRELAND LTD
Model
G34281
Catalog number
ECHO-HD-22-EBUS-O-C
Device description
Echotip Procore, Endobronchial HD Ultrasound Biopsy Needle for Olympus Scopes
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCGBiopsy needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002342811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002342811008270023428118270023428110827002342811

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10827002256702SolusG25670ZSS-10-3-RB2015-10-24
10827002256719SolusG25671ZSS-10-4-RB2015-10-24
10827002256726SolusG25672ZSS-10-5-RB2015-10-24
10827002256733SolusG25673ZSS-10-7-RB2015-10-24
10827002256740SolusG25674ZSS-10-9-RB2015-10-24
10827002256757SolusG25675ZSS-10-12-RB2015-10-24
10827002256764SolusG25676ZSS-10-15-RB2015-10-24
10827002256856SolusG25685ZSS-10-10-RB2015-10-24
10827002268293SolusG26829ZSS-10-1-RB2015-10-24
10827002496559Cotton-Leung Sof-FlexG49655CLSO-SF-10-92015-11-03
10827002496566Cotton-Leung Sof-FlexG49656CLSO-SF-10-122015-11-03
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
10827002496719Geenen Sof-FlexG49671GPSOS-SF-5-92015-11-03
10827002496726Geenen Sof-FlexG49672GPSOS-SF-5-122015-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18809327353412ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355539ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355546ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355553ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355560ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355577ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355966ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355973ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355980ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327355997ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356000ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356017ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356024ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356031ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356048ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356055ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356062ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356079ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
18809327356086ClearTipFINEMEDIX CO.,LTD.FCG2026-03-24
20884450476127CorVocet™Merit Medical Systems, Inc.FCG2026-02-28
00860014682926PrecisionPoint Corbin Clinical Resources, LLCFCG2026-02-04
14953170459204Single-use Fine Needle Biopsy (FNB) Device NA-U210HOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
14953170459259Single-use Fine Needle Biopsy (FNB) Device NA-U210HOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
14953170459310Single-use Fine Needle Biopsy (FNB) Device NA-U210HOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
04048223128480ChibaSonoPajunk GmbH MedizintechnologieFCG2025-07-30
08033003340806BIOMOLH.S. HOSPITAL SERVICE SPAFCG2025-07-07
08033055140300BIOMOLH.S. HOSPITAL SERVICE SPAFCG2025-07-07
04048223128268ChibaSonoPajunk GmbH MedizintechnologieFCG2025-06-17
04048223128275ChibaSonoPajunk GmbH MedizintechnologieFCG2025-06-17
04048223128336ChibaSonoPajunk GmbH MedizintechnologieFCG2025-06-17