FDA.report

TI rod 6x140mm cvd.

Primary DI
EMAHSCC0301401
Brand
TI rod 6x140mm cvd.
Company
mahe medical gmbh
Model
SCC03-0140
Catalog number
SCC03-0140
Device description
TI rod 6x140mm cvd.
Published
2016-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EMAHSCC0301401PackageHIBCC1In Commercial Distribution
EMAHSCC0301400PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+49(0)746592750info@mahe-med.de

Regulatory Flags

DUNS number
342243334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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04050659161702mahe medical GmbH001-0001-006S2019-11-05
04050659161719mahe medical GmbH001-0001-006ST2019-11-05
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04050659161740mahe medical GmbH001-0001-007S2019-11-05
04050659161757mahe medical GmbH001-0001-007ST2019-11-05
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04050659161825mahe medical GmbH001-0001-009S2019-11-05
04050659161849mahe medical GmbH001-0001-009XS2019-11-05
04050659161863mahe medical GmbH001-0001-010S2019-11-05
04050659161887mahe medical GmbH001-0001-010XS2019-11-05
04050659161948mahe medical GmbH001-0001-012S2019-11-05
04050659161962mahe medical GmbH001-0001-012XS2019-11-05
04050659162013mahe medical GmbH001-0001-014S2019-11-05
04050659162037mahe medical GmbH001-0001-014XS2019-11-05
04050659162051mahe medical GmbH001-0001-016S2019-11-05
04050659162068mahe medical GmbH001-0001-016ST2019-11-05
04050659162075mahe medical GmbH001-0001-016XS2019-11-05
04050659162112mahe medical GmbH001-0001-018XS2019-11-05
04050659162150mahe medical GmbH001-0001-020XS2019-11-05

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