DEVICE: Xcel (07613154092604)

Device Identifier (DI) Information

Xcel
3910-300-015
In Commercial Distribution
3910-300-015
STRYKER CORPORATION
07613154092604
GS1

1
187502109 *Terms of Use
3MM XCEL WITH 1 STRAND #2 FORCE FIBER
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Soft-tissue anchor, bioabsorbable A device designed to be implanted into bone for the attachment of soft tissues either directly or via a suture attached to the device; it is not dedicated to ligament anchoring. It is typically used in arthroscopic or open surgical procedures, and functions as an alternative to drilling a tunnel in bone for passing a suture. 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).
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FDA Product Code

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Product Code Product Code Name
MAI FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041307 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 54 Degrees Celsius
Handling Environment Temperature: less than 54 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Diameter: 3.0 Millimeter
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Device Record Status

2a9a3705-aad5-412b-b1d2-7d568ed8b57c
July 06, 2018
3
September 08, 2015
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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 In Commercial Distribution pack
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(866)624-4422
xx@xx.xx
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