Indy OTW

Primary DI
00827002518360
Brand
Indy OTW
Company
COOK INCORPORATED
Model
G51836
Catalog number
INDY-8.0-35-100-40
Device description
Indy OTW Vascular Retriever
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
MMXDevice, percutaneous retrieval

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMXDevice, Percutaneous RetrievalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002518360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002518360008270025183608270025183600827002518360

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
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762407Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762414Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762421Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762438Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00850041730141LimFlow V-CeiverLimflow Inc.MMX2024-03-09
20827002132874Gunther TulipCOOK INCORPORATEDMMX2023-12-04
00860008180605ONO Retrieval DeviceOnocor LLCMMX2023-08-04
00850041730004LimFlow V-CeiverLimflow Inc.MMX2023-06-26
10884450681739ONE Snare®Merit Medical Systems, Inc.MMX2023-04-21
05415067034496Aveir™ST. JUDE MEDICAL, INC.MMX2023-03-03
10884450681746ONE Snare®Merit Medical Systems, Inc.MMX2023-02-22
10884450681845ONE Snare®Merit Medical Systems, Inc.MMX2023-02-09
10884450681722ONE Snare®Merit Medical Systems, Inc.MMX2023-02-01
10884450681715ONE Snare®Merit Medical Systems, Inc.MMX2023-01-20
10884450681784ONE Snare®Merit Medical Systems, Inc.MMX2023-01-13
10884450681760ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
10884450681807ONE Snare®Merit Medical Systems, Inc.MMX2022-12-16
10884450681838ONE Snare®Merit Medical Systems, Inc.MMX2022-12-15
10884450681821ONE Snare®Merit Medical Systems, Inc.MMX2022-12-02
10884450681708ONE Snare®Merit Medical Systems, Inc.MMX2022-10-26
10884450572129Medtronic Retrieval Snare Kit SystemMerit Medical Systems, Inc.MMX2022-04-27
B342CAP14120Captus Vascular Retrieval SystemAvantec Vascular CorporationMMX2021-07-13
10884450491321EMPOWER™Merit Medical Systems, Inc.MMX2021-07-08
10884450493431EMPOWER™Merit Medical Systems, Inc.MMX2021-07-08
00886333224609Single-Loop Snare Retrieval KitARGON MEDICAL DEVICES, INC.MMX2021-06-16
00886333224616Triple-Loop Snare Retrieval KitARGON MEDICAL DEVICES, INC.MMX2021-06-16
00886333224791Halo™ Single-Loop Microsnare KitARGON MEDICAL DEVICES, INC.MMX2021-01-18
00886333224807Halo™ Single-Loop Microsnare KitARGON MEDICAL DEVICES, INC.MMX2021-01-18
00886333224814Halo™ Single-Loop Microsnare KitARGON MEDICAL DEVICES, INC.MMX2021-01-18