DEVICE: PANALOK PANACRYL (10886705001156)
Device Identifier (DI) Information
PANALOK PANACRYL
210725
In Commercial Distribution
210725
DEPUY MITEK, LLC
210725
In Commercial Distribution
210725
DEPUY MITEK, LLC
PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) PANACRYL absorbable braided suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
45061 | Tendon/ligament bone anchor, bioabsorbable |
A 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 can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
HRX | ARTHROSCOPE |
MBI | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
HTY | PIN, FIXATION, SMOOTH |
JDR | Staple, fixation, bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150209 | 000 |
K952687 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 80 Degrees Fahrenheit |
Handling Environment Temperature: less than 26 Degrees Celsius |
Handling Environment Temperature: less than 80 Degrees Fahrenheit |
Storage Environment Temperature: less than 26 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
25575908-9bae-4d81-bf8f-857597b3d872
February 17, 2025
5
September 01, 2015
February 17, 2025
5
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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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