ONO Retrieval Device

Primary DI
00860008180605
Brand
ONO Retrieval Device
Company
Onocor LLC
Model
ONO12-100
Device description
Retrieval catheter with peel away sheath
Published
2023-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212988000ONO Retrieval DeviceOnocor Vascular, LLC2022-05-23MMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008180605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008180605008600081806058600081806050860008180605

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular extraction catheter-snareA 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)].

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
8778362228katy@onocorvascular.com

Regulatory Flags#

DUNS number
079891686
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762391Amplatz 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-CeiverInari Medical, Inc.MMX2024-03-09
20827002132874Gunther TulipCOOK INCORPORATEDMMX2023-12-04
00850041730004LimFlow V-CeiverInari Medical, Inc.MMX2023-06-26
00884450681732ONE Snare®Merit Medical Systems, Inc.MMX2023-04-21
10884450681739ONE Snare®Merit Medical Systems, Inc.MMX2023-04-21
05415067034496Aveir™ST. JUDE MEDICAL, INC.MMX2023-03-03
00884450681749ONE Snare®Merit Medical Systems, Inc.MMX2023-02-22
10884450681746ONE Snare®Merit Medical Systems, Inc.MMX2023-02-22
00884450681848ONE Snare®Merit Medical Systems, Inc.MMX2023-02-09
10884450681845ONE Snare®Merit Medical Systems, Inc.MMX2023-02-09
00884450681725ONE Snare®Merit Medical Systems, Inc.MMX2023-02-01
10884450681722ONE Snare®Merit Medical Systems, Inc.MMX2023-02-01
00884450681718ONE Snare®Merit Medical Systems, Inc.MMX2023-01-20
10884450681715ONE Snare®Merit Medical Systems, Inc.MMX2023-01-20
00884450681787ONE Snare®Merit Medical Systems, Inc.MMX2023-01-13
10884450681784ONE Snare®Merit Medical Systems, Inc.MMX2023-01-13
00884450681763ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
10884450681760ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
00884450681800ONE Snare®Merit Medical Systems, Inc.MMX2022-12-16
10884450681807ONE Snare®Merit Medical Systems, Inc.MMX2022-12-16
00884450681831ONE Snare®Merit Medical Systems, Inc.MMX2022-12-15