DEVICE: MEITAC (E0HM79MT0019)

Device Identifier (DI) Information

MEITAC
BMPBA
In Commercial Distribution
BMPBA
Hager & Meisinger Gesellschaft mit beschränkter Haftung
E0HM79MT0019
HIBCC

1
318034329 *Terms of Use
The system MEITAC consist of Tacs and neccessary accessories. The system contains 20 Tacs. Tacs are used for the fixation of membranes (resorbable membranes nonresorbable membranes) to the bone structure. Tacs are intended for single use only. The Tacs consist of titanium alloy Grade 5 and are delivered non sterile.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Craniofacial bone tack, non-bioabsorbable A small, sterile, cylindrical shaft typically with a flat, rounded head at one end and tapered to a point at the other, that is driven into craniofacial bone (includes maxilla and/or mandible) to provide stabilization for fracture repair and reconstructive procedures; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., titanium alloy). The device may be used when rigid fixation with bone plates and screws is not required.
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FDA Product Code

[?]
Product Code Product Code Name
DZL Screw, Fixation, Intraosseous
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

87fcfd3f-1d2d-431d-aa5e-9b550a7450dc
March 29, 2018
2
July 13, 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

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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
No
No
No CLOSE

Customer Contact

[?]
+1 (303) 268-5400
info@meisingerusa.com
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