FDA.reportPublic FDA data

EMPOWER™

Primary DI
10884450493431
Brand
EMPOWER™
Company
Merit Medical Systems, Inc.
Model
00884450493434
Catalog number
8785
Published
2021-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450493431PackageGS120In Commercial Distribution
00884450493434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445049343110884450493431
00884450493434008844504934348844504934340884450493434

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)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
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
false
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
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
00884450392928SCOUT MD™Initial ReleaseMDS10M-012026-05-21
00884450394427SCOUT MD™Initial ReleaseMDS75SB-012026-05-21
00884450399170SCOUT MD™Initial ReleaseMDS75SC-012026-05-21
00884450436066Merit Medical®Initial ReleaseK08-02870A2026-05-21
00884450436172Merit Medical®Initial ReleaseK09-14009A2026-05-21
00884450122679Merit Medical®Initial ReleaseK08-02092B2026-05-20
00884450180075Merit Medical®Initial ReleaseK09-13303A2026-05-20
00884450424636Merit Medical®Initial ReleaseK09-13719B2026-05-20
00884450437988Merit Disposal Depot™Initial ReleaseK10-00577B2026-05-20

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