DEVICE: Xcel (07613154092604)
Device Identifier (DI) Information
Xcel
3910-300-015
Not in Commercial Distribution
3910-300-015
STRYKER CORPORATION
3910-300-015
Not in Commercial Distribution
3910-300-015
STRYKER CORPORATION
3MM XCEL WITH 1 STRAND #2 FORCE FIBER
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).
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K041307 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 54 Degrees Celsius |
Handling Environment Temperature: less than 54 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Diameter: 3.0 Millimeter |
Device Record Status
2a9a3705-aad5-412b-b1d2-7d568ed8b57c
December 12, 2022
7
September 08, 2015
December 12, 2022
7
September 08, 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 |
---|---|---|---|---|---|
37613154092605 | 5 | 07613154092604 | 2022-12-11 | Not in Commercial Distribution | pack |
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(866)624-4422
xx@xx.xx
xx@xx.xx