DEVICE: SofTIP (10840143909641)
Device Identifier (DI) Information
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
64565 | Pericardioscopic access cannula |
A rigid, single-lumen, surgical instrument intended to be percutaneously inserted through the chest and through the pericardial cavity to facilitate the introduction of surgical instruments as part of a minimally-invasive cardiac procedure (e.g., epicardial ablation). It is intended for subxiphoid or transdiaphragmatic access, and once in place is intended to remain in position for the duration of the procedure. It may include a trocar blade intended to assist introduction. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K090385 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dry place |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3b9506c5-cc5f-47a9-a91f-aaed99d0925a
April 14, 2023
1
April 06, 2023
April 14, 2023
1
April 06, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30840143909645 | 1 | 10840143909641 | In Commercial Distribution | box | |
50840143909649 | 10 | 30840143909645 | In Commercial Distribution | case |
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
[?]
866-449-2342
SEhlert@atricure.com
SEhlert@atricure.com