FDA.reportPublic FDA data

Needle's Eye

Primary DI
00827002265189
Brand
Needle's Eye
Company
COOK INCORPORATED
Model
G26518
Catalog number
LR-SSN001
Device description
Needle's Eye Snare and 12 Fr Straight Inner Femoral Sheath
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
DXECatheter, embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002265189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002265189008270022651898270022651890827002265189

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular catheter-snareA sterile, flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
042823948
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
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20841156110519PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
00850291007697Large Bore 60 cc SyringeINARI MEDICAL INCDXE2024-12-20
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
08886483507524Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2023-10-31
00860010378007ICHORICHOR VASCULAR, INC.DXE2023-10-13
20801902196600ARROWTELEFLEX INCORPORATEDDXE2022-11-15
20801902194040ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194057ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194064ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194071ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194088ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194095ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194101ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902196617ARROWTELEFLEX INCORPORATEDDXE2022-11-08
00815948023802Indigo SystemPENUMBRA, INC.DXE2022-09-01
00815948023857Indigo SystemPENUMBRA, INC.DXE2022-09-01
00815948024281IndigoPENUMBRA, INC.DXE2022-03-04
00815948024335Indigo SystemPENUMBRA, INC.DXE2022-03-04
00815948024342Indigo SystemPENUMBRA, INC.DXE2022-03-04
00840663109616Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109623Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109630Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109647Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109654Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109661Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109678Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109685Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18