Home GUDID M906BARMALLET0 Surgical Mallet (Slotted)
Primary DI M906BARMALLET0
Brand Surgical Mallet (Slotted)
Company INTRINSIC THERAPEUTICS, INC.
Model 400929
Catalog number BAR-MALLET
Device description Surgical mallet (slotted), for general use as well as specifically to support implantation of the Barricaid® Annular Closure Device (ACD).
Published 2020-02-04
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M906BARMALLET0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 105722131 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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 Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M906BARMALLETA0 Surgical Mallet (Slotted) 400932 BAR-MALLET-A 2026-09-04 M906KITD7NARROW0 Barricaid® Narrow Anchor ACD - Reusable Instruments Kit 4001009 KIT-D7-NARROW 2026-01-15 M906AT10NARROW0 Barricaid® Narrow Anchor ACD Alignment Trial (10mm) 400944 AT-10-NARROW 2026-01-15 M906AT8NARROW0 Barricaid® Narrow Anchor ACD Alignment Trial (8mm) 400943 AT-8-NARROW 2026-01-15 M906BARA610MM0 Barricaid® Narrow Anchor ACD (Annular Closure Device) 2741015-A6 BAR-A6-10MM 2026-01-15 M906BARA68MM0 Barricaid® Narrow Anchor ACD (Annular Closure Device) 2740815-A6 BAR-A6-8MM 2026-01-15 M906BARIMPACTOR0 Barricaid® ACD Impactor 400906-A BAR-IMPACTOR 2020-02-04 M906WED1A0 Barricaid ACD Retraction Wedge 400846 WED-1-A 2019-05-14 M906KITD70 Barricaid® ACD - Reusable Instruments Kit 4001007 KIT-D7 2021-02-15 M906BARAT100 Barricaid® ACD Alignment Trial (10mm) 400877 BAR-AT-10 2020-02-04 M906BARAT80 Barricaid® ACD Alignment Trial (8mm) 400879 BAR-AT-8 2020-02-04 M906BARDMT10X110 Defect Measurement Tool (10/11mm) 400212 BAR-DMT-10X11 2020-02-04 M906BARDMT12X130 Defect Measurement Tool (12/13mm) 400213 BAR-DMT-12X13 2020-02-04 M906BARDMT4X50 Defect Measurement Tool (4/5mm) 400209 BAR-DMT-4X5 2020-02-04 M906BARDMT6X70 Defect Measurement Tool (6/7mm) 400210 BAR-DMT-6X7 2020-02-04 M906BARDMT8X90 Defect Measurement Tool (8/9mm) 400211 BAR-DMT-8X9 2020-02-04 M906BARWEDGE0 Barricaid® ACD Retraction Wedge 400846 BAR-WEDGE 2020-02-04 M906KITD4C10 Barricaid® ACD - Reusable Instruments Kit (Tray Only) 400885 KIT-D4-C1 2020-02-04 M906KITD40 Barricaid® ACD - Reusable Instruments Kit 4001004 KIT-D4 2019-05-14 M906DMT10X11A0 Defect Measurement Tool (10/11mm) 400212 DMT-10X11-A 2019-05-14
in-thera.com