DEVICE: DELTA (07613252444237)

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Device Record History
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Device Identifier (DI) Information
DELTA
70-92004
In Commercial Distribution
70-92004
Stryker Leibinger GmbH & Co. KG
07613252444237
GS1

1
316153956 *Terms of Use
Delta 1.7mm Plate 2x21 holes x 0.5mm
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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?
46641 Craniofacial fixation plate, bioabsorbable
A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of bioabsorbable materials (e.g., degradable polymer) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or bioabsorbable plate fixation implants (i.e., bone screws), may be included with the plate.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HRS Plate, fixation, bone
HBW FASTENER, PLATE, CRANIOPLASTY
JEY PLATE, BONE
GXR COVER, BURR HOLE
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K113109 000
K213777 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 49 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Thickness: 0.5 Millimeter
Device Size Text, specify: 3D Plates: 2x21 Holes
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Device Record Status
6cd859c2-6501-40d9-9ab5-a6623c19210f
September 18, 2023
9
September 24, 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
No Package DIs found
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Secondary DI

[?]
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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