DEVICE: HEALIX ADVANCE PERMACORD (10886705024773)
Device Identifier (DI) Information
HEALIX ADVANCE PERMACORD
223137
In Commercial Distribution
223137
Medos International Sàrl
223137
In Commercial Distribution
223137
Medos International Sàrl
HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ PERMACORD PEEK Anchor (1) Blue (1) White/Black (1) White/Green, Size 2 (5 Metric) PERMACORD Suture, 36 Inches (91cm) 5.5mm
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? |
---|---|---|---|---|
45062 | Tendon/ligament bone anchor, non-bioabsorbable |
A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWC | Screw, fixation, bone |
MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: less than 25 Degrees Celsius |
Handling Environment Temperature: less than 77 Degrees Fahrenheit |
Storage Environment Temperature: less than 25 Degrees Celsius |
Storage Environment Temperature: less than 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bab98fa3-0fa0-4546-a945-7d9c58989f05
December 22, 2023
6
September 01, 2015
December 22, 2023
6
September 01, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(800)255-2500
xx@xx.xx
xx@xx.xx