GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)

GUDID 00613994985712

DBM P44115 15CC GRAFTON CRUNCH

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived

• Primary Device ID: 00613994985712
• NIH Device Record Key: a8e31c09-81ea-4c6b-b69b-d46c8acbcfe4
• Commercial Distribution Discontinuation: 2015-11-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)
• Version Model Number: P44115
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994985712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051195

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-20

On-Brand Devices [GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)]

• 00643169134362: DBM T44150INT 10CC GRAFTON ORTHOBLEND SM
• 00643169134355: DBM T44145INT 5CC GRAFTON ORTHOBLEND SM
• 00643169134348: DBM T44135INT 15CC GRAFTON ORTHOBLEND LG
• 00643169134331: DBM T44125INT 5CC GRAFTON ORTHOBLEND LG
• 00643169134317: DBM T44105INT 5CC GRAFTON CRUNCH
• 00643169123175: DBM T43102 1CC GRAFTON PUTTY
• 00643169123168: DBM T43103 2.5CC GRAFTON PUTTY
• 00643169123151: DBM T43105 5CC GRAFTON PUTTY
• 00643169123144: DBM T43110 10CC GRAFTON PUTTY
• 00643169123137: DBM T43204 0.25CC GRAFTON PUTTY SYRINGE
• 00643169123120: DBM T44105 5CC GRAFTON CRUNCH
• 00643169123113: DBM T44115 15CC GRAFTON CRUNCH
• 00643169123106: DBM T43101 0.5CC GRAFTON PUTTY
• 00643169123090: DBM T42308 GRAFTON MATRIX PLUGS 8MMX10MM
• 00643169123083: DBM T42280 8MMX1CMX20CM 2 EACH GRAFTON M
• 00643169123076: DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M
• 00643169123069: DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR
• 00643169123052: DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT
• 00643169123045: DBM T42160 GRAFTON A FLEX 6 CM DIA
• 00643169123038: DBM T45010 10CC PASTE GRAFTON PLUS
• 00643169123021: DBM T45005 5CC PASTE GRAFTON PLUS
• 00643169123014: DBM T42110 2.5CMX5CM FLEXGRAFTON
• 00643169123007: DBM T42100 2.5CMX10CM FLEX GRAFTON
• 00643169122994: DBM T42090 1.5CMX1.5CM FLEX GRAFTON
• 00643169122987: DBM T41150 10CC GRAFTON GEL
• 00643169122970: DBM T41130 5CC GRAFTON GEL
• 00643169122963: DBM T41120 1CC GRAFTON GEL
• 00643169122956: DBM T41110 0.5CC GRAFTON GEL
• 00643169122949: DBM T45001 1CC PASTE GRAFTON PLUS
• 00643169122932: DBM T44150 10CC ORTHOBLEND SMALL DEFGRAF
• 00643169122925: DBM T44145 5CC ORTHOBLEND SMALL DEFGRAFT
• 00643169122918: DBM T44135 15CC ORTHOBLEND LARGE DEFGRAF
• 00643169122901: DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT
• 00643169068650: DBM P43205 0.5CC GRAFTON PUTTY SYRINGE
• 00643169068636: DBM A43205 0.5CC GRAFTON PUTTY SYRINGE
• 00643169001060: DBM P42150 5CM X 5CM FLEX GRAFTON
• 00643169001046: DBM A42150 5CM X 5CM FLEX GRAFTON
• 00613994986214: DBM A45010 10CC PASTE GRAFTON PLUS
• 00613994986207: DBM A45005 5CC PASTE GRAFTON PLUS
• 00613994986191: DBM A45001 1CC PASTE GRAFTON PLUS
• 00613994986184: DBM A44150 10CC ORTHOBLEND SMALL DEFGRAF
• 00613994986177: DBM A44145 5CC ORTHOBLEND SMALL DEFGRAFT
• 00613994986160: DBM A44135 15CC ORTHOBLEND LARGE DEFGRAF
• 00613994986153: DBM A44125 5CC ORTHOBLEND LARGE DEFGRAFT
• 00613994986146: DBM A44115 15CC GRAFTON CRUNCH
• 00613994986030: DBM A41110 0.5CC GRAFTON GEL
• 00613994986023: DBM A41120 1CC GRAFTON GEL
• 00613994986016: DBM A41130 5CC GRAFTON GEL
• 00613994986009: DBM A41150 10CC GRAFTON GEL
• 00613994985996: DBM A42090 1.5CMX1.5CM FLEX GRAFTON