FDA.reportPublic FDA data

Bard Snare US

Primary DI
00857834006544
Brand
Bard Snare US
Company
HERAEUS MEDICAL COMPONENTS LLC
Model
SRK30
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K152560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152560000Bard Snare Retrieval KitNeometrics, Inc.2015-10-23MMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857834006544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857834006544008578340065448578340065440857834006544

GMDN Terms#

Term, Definition table
TermDefinition
Vena cava filter extraction/repositioning kitA collection of sterile devices designed to perform the percutaneous retrieval or repositioning of an implanted inferior vena cava (IVC) filter. It will typically contain various dedicated catheters with dilating, pushing, and retrieval functions (e.g., gripping claws, loop/lasso) and devices such as needles and guide wires. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
868303074
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002448469Motion Hybrid Wire GuideMHW-0351502021-09-09
00827002448483Motion Hybrid Wire GuideMHW-0381502021-09-09
00827002448490Motion Hybrid Wire GuideMHWA-0381502021-09-09
00827002448551Motion Hybrid Wire GuideMHWA-0351502021-09-09
08714729892038NovaGold5200M005520002016-09-21
08714729892045NovaGold5201M005520102016-09-21
00857834006070ERCPGI1012016-09-21
00857834006087ERCPGI1022016-09-21
00857834006094ERCPGI1032016-09-21
00857834006100ERCPGI1042016-09-21
00857834006117ERCPGI1052016-09-21
00857834006124ERCPGI1062016-09-21
00857834006131ERCPGI1072016-09-21
00857834006148ERCPGI1082016-09-21
00857834006155ERCPGI1092016-09-21
00857834006162ERCPGI1102016-09-21
00857834006179ERCPGI1112016-09-21
00857834006186ERCPGI1122016-09-21
00857834006193ERCPGI1132016-09-21
00857834006209ERCPGI1142016-09-21

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
00860008180605ONO Retrieval DeviceOnocor LLCMMX2023-08-04
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