DEVICE: Brånemark System® (07332747004991)

Device Identifier (DI) Information

Brånemark System®
28979
In Commercial Distribution
28979
Nobel Biocare AB
07332747004991
GS1

1
353939929 *Terms of Use
Bone Mill Brånemark System® WP
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Manual bone mill A manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
DZI DRILL, BONE, POWERED
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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

061d0115-cde8-4e61-a8a6-4f91bf95aa65
October 05, 2018
3
September 17, 2016
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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
No
No
No CLOSE

Customer Contact

[?]
+1(800)322-5001
us.customerservice@nobelbiocare.com
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