DEVICE: MANTA (00856279007079)
Device Identifier (DI) Information
MANTA
2156
In Commercial Distribution
ESSENTIAL MEDICAL, INC.
2156
In Commercial Distribution
ESSENTIAL MEDICAL, INC.
14F MANTA Vascular Closure Device
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60710 | Femoral artery closure plug/patch, collagen |
An implantable, bioabsorbable device designed for haemostasis/closure of a puncture site, through pressure/compression, on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression or surgical techniques to reduce the time to haemostasis. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MGB | Device, Hemostasis, Vascular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3e814640-c47e-482f-8c87-7345fc76cba5
February 05, 2021
3
February 08, 2019
February 05, 2021
3
February 08, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00856279007109 | 5 | 00856279007079 | In Commercial Distribution | Shelf Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
866-246-6990
cs@teleflex.com
cs@teleflex.com