FDA.report

MASTERGRAFT® MATRIX EXT

Primary DI
00643169574373
Brand
MASTERGRAFT® MATRIX EXT
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7610320
Device description
BLOCKS 7610320 MSTRGRFT MATRIX EXT 20CC
Published
2015-07-20
Public version status
Update
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
MQVFILLER, BONE VOID, CALCIUM COMPOUND

Product Code Classifications

CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00643169574373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169574373006431695743736431695743730643169574373

GMDN Terms

TermDefinition
Bone matrix implant, animal-derived, bioabsorbableA sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
830350380
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
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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