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Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton Plus DBM Paste - Medtronic Australasia Pty Ltd - Implant - Syringe, Medtronic Australasia Pty Ltd, CON-1010
Product name
Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton Plus DBM Paste - Medtronic Australasia Pty Ltd - Implant - Syringe
Sponsor name
Medtronic Australasia Pty Ltd
Batches
T45001AUS - 310 units T45010AUS -123 units
Consent start
Consent no.
CON-1010
Duration
The consent is effective from the 21 September 2022 until 21 December 2022.
Standard
Clause 11(18) of the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order.
Non-compliance with standard
The products do not conform with clause 11(18) of TGO 108 that specifies that
the serum or plasma of a blood sample taken from a donor of HCT materials must
be retained for a minimum of two years after the expiry date of the relevant HCT
product, or for a period that is validated on the basis of validated data or
documented evidence from relevant scientific literature.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Blood, tissues, and biologicals