DEVICE: CRANIOFIX2 (04038653379576)

Device Identifier (DI) Information

CRANIOFIX2
FF490T
In Commercial Distribution
FF490T
Aesculap AG
04038653379576
GS1

12
315018218 *Terms of Use
CRANIOFIX 2 TITANIUM CLAMP 11MM
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Device Characteristics

MR Conditional
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
Cranial bur hole cover A sterile device used to cover or to plug holes drilled into the skull during surgery and to reattach cranial bone removed during the intervention. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GXN PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
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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

[?]
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

6d346149-13b2-4a6a-a890-554bd47bec89
March 29, 2018
2
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: 04038653379569 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(800)282-9000
GUDID.BBMUS_Service@bbraun.com
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