DEVICE: BREMER (10705034341927)
Device Identifier (DI) Information
BREMER
HT022
Not in Commercial Distribution
HT022
DEPUY SPINE, LLC
HT022
Not in Commercial Distribution
HT022
DEPUY SPINE, LLC
BREMER HALO ADJUSTABLE RING SYSTEM C ADJUSTABLE RING 21-26 in. (53-66 cm)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60367 | Cervical spine immobilization system, single-use |
An assembly of orthopaedic devices designed to immobilize the cervical spine (the bones in the neck) after an injury or surgery, to protect the bones from damaging movement during the healing processes. Commonly known as a Halo vest, it typically consists of a ring(s) around the head (the halo) which is attached to the skull with threaded bolts, a special padded vest/harness, four rods with locking mechanisms connecting the head ring to the vest, together with the appropriate instrumentation. This device may be made of ferrous or non-ferromagnetically active materials [to allow magnetic resonance imaging (MRI)], and is available in various sizes. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JEC | COMPONENT, TRACTION, INVASIVE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K915800 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4facb118-a09c-4b4a-8a0c-9a7754fae0a7
July 06, 2018
5
September 24, 2015
July 06, 2018
5
September 24, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)255-2500
xx@xx.xx
xx@xx.xx