FDA.report

Medtronic Reusable Instrument

Primary DI
00763000211035
Brand
Medtronic Reusable Instrument
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
6550202
Device description
FNS TIP 6550202 BOX OF 2 FNS TIPS
Published
2022-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KIHDISPENSER, CEMENT

Product Code Classifications

CodeDeviceSpecialtyClass
KIHDispenser, CementOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20763000211039PrimaryGS10
00763000211035Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300021103920763000211039
00763000211035007630002110357630002110350763000211035

GMDN Terms

TermDefinition
Orthopaedic cement dispenserA syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
830350380
Device count
2
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
false

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