DEVICE: DELTA (07613252457411)

Device Identifier (DI) Information

DELTA
73-22004
In Commercial Distribution
73-22004
Stryker Leibinger GmbH & Co. KG
07613252457411
GS1

1
316153956 *Terms of Use
DELTA 2.2X4MM SCREW, 1 EA
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Craniofacial bone screw, bioabsorbable A small, sterile, threaded rod with a slotted head used for craniofacial bone (including the maxilla and/or mandible) fracture fixation by being screwed into bone to hold plates to bone or to provide direct interfragmentary stabilization of bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation.
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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 [?]
K993061 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: less than 49 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 4.0 Millimeter
Device Size Text, specify: Diameter: 2.2 Millimeter
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Device Record Status

31cb77ed-a8ae-428d-9300-ab0fc389e6d7
July 06, 2018
3
September 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

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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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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