FDA.report

Medtronic Resuable Instruments

Primary DI
00643169986381
Brand
Medtronic Resuable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX0217082
Device description
ROD HOLDER EX0217082 3.5MM
Published
2022-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTCPLIERS, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
HTCPliers, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00643169986381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169986381006431699863816431699863810643169986381

GMDN Terms

TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
830350380
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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