DEVICE: HTR-PMI (00841036227197)

Device Identifier (DI) Information

HTR-PMI
PM619058
In Commercial Distribution

BIOMET MICROFIXATION, INC
00841036227197
GS1

1
046189866 *Terms of Use
No description.
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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
Cranioplasty plate, non-alterable An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.
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FDA Product Code

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Product Code Product Code Name
FZE Prosthesis, Nose, Internal
FWP Prosthesis, Chin, Internal
LZK Implant, Malar
KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
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FDA Premarket Submission

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

Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

31e30d92-6901-4a36-a980-7cc8b60390f0
March 29, 2018
2
February 06, 2017
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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

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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
No
No CLOSE

Customer Contact

[?]
+1(904)741-4400
FXJAX-ORDERS@ZIMMERBIOMET.COM
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