DEVICE: BREMER (10705034244334)

Device Identifier (DI) Information

BREMER
CLP010
Not in Commercial Distribution
CLP010
DEPUY SPINE, LLC
10705034244334
GS1
June 20, 2018
1
107105876 *Terms of Use
BREMER HALO SYSTEM TONG ADAPTER KIT
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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
Surgical traction skull tongs An instrument used during orthopaedic surgery to perform traction on the cervical spine by applying an upward force to the skull that causes hyperextension of the head and neck. It is typically a two-arm pivoted instrument that is attached to the skull using pins (either partially implanted or not); the proximal end includes a mechanism (e.g., an adjustable threaded bolt and nut) responsible for the application of the traction force. This device is typically used during procedures to treat a fractured spine. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

23310429-9160-4186-a9e8-c67da553b902
June 20, 2018
4
December 31, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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