DEVICE: TI rod 6x60mm cvd. (EMAHSCC0300600)
Device Identifier (DI) Information
TI rod 6x60mm cvd.
SCC03-0060
In Commercial Distribution
SCC03-0060
mahe medical gmbh
SCC03-0060
In Commercial Distribution
SCC03-0060
mahe medical gmbh
TI rod 6x60mm cvd.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
61325 | Bone-screw internal spinal fixation system, non-sterile |
An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 28 Degrees Celsius |
Special Storage Condition, Specify: cool, dry & dark place |
Storage Environment Humidity: between 10 and 50 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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Length: 60.0 Millimeter |
Outer Diameter: 6.0 Millimeter |
Device Record Status
d1ea009b-683d-409f-a373-ffe8bdb49a71
March 29, 2018
2
August 04, 2016
March 29, 2018
2
August 04, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
EMAHSCC0300601 | 1 | EMAHSCC0300600 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+49(0)746592750
info@mahe-med.de
info@mahe-med.de