FDA.report

Medtronic Reusable Instruments

Primary DI
00673978145372
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0797-035
Device description
PROV CRIMP W/ MOD THUMB LEVER
Published
2022-10-07
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
HXQCRIMPER, PIN

Product Code Classifications

CodeDeviceSpecialtyClass
HXQCrimper, PinOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00673978145372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673978145372006739781453726739781453720673978145372

GMDN Terms

TermDefinition
Internal spinal fixation system cable crimperA scissors-like, heavy-duty, hand-held manual surgical instrument specifically designed to compress (pinch) fixation crimps that are applied to spinal fixation cable(s). The device is used in conjunction with a cable tensioner to lock into final position the cables used to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically designed to be operated by a surgeon with the cable(s) in situ. 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
false
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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