FDA.report

n/a

Primary DI
00763000216740
Brand
n/a
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
6550041
Device description
VOYAGER 6550041 CEMENT DELIVERY GUIDE
Published
2020-03-22
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
KIHDISPENSER, CEMENT

Product Code Classifications

CodeDeviceSpecialtyClass
KIHDispenser, CementOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000216740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000216740007630002167407630002167400763000216740

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
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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