FDA.reportPublic FDA data

Defect Measurement Tool (4/5mm)

Primary DI
M906BARDMT4X50
Brand
Defect Measurement Tool (4/5mm)
Company
INTRINSIC THERAPEUTICS, INC.
Model
400209
Catalog number
BAR-DMT-4X5
Device description
Stainless steel rod with specific sized ends (4 and 5 mm) for aiding in the measurement of soft tissue defects.
Published
2020-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M906BARDMT4X50PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA 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. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface 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

Contacts#

Phone, Email table
PhoneEmail
781.932.0222info@in-thera.com

Regulatory Flags#

DUNS number
105722131
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M906KITD7NARROW0Barricaid® Narrow Anchor ACD - Reusable Instruments Kit4001009KIT-D7-NARROW2026-01-15
M906AT10NARROW0Barricaid® Narrow Anchor ACD Alignment Trial (10mm)400944AT-10-NARROW2026-01-15
M906AT8NARROW0Barricaid® Narrow Anchor ACD Alignment Trial (8mm)400943AT-8-NARROW2026-01-15
M906BARA610MM0Barricaid® Narrow Anchor ACD (Annular Closure Device)2741015-A6BAR-A6-10MM2026-01-15
M906BARA68MM0Barricaid® Narrow Anchor ACD (Annular Closure Device)2740815-A6BAR-A6-8MM2026-01-15
M906BARIMPACTOR0Barricaid® ACD Impactor400906-ABAR-IMPACTOR2020-02-04
M906WED1A0Barricaid ACD Retraction Wedge400846WED-1-A2019-05-14
M906KITD70Barricaid® ACD - Reusable Instruments Kit4001007KIT-D72021-02-15
M906BARAT100Barricaid® ACD Alignment Trial (10mm)400877BAR-AT-102020-02-04
M906BARAT80Barricaid® ACD Alignment Trial (8mm)400879BAR-AT-82020-02-04
M906BARDMT10X110Defect Measurement Tool (10/11mm)400212BAR-DMT-10X112020-02-04
M906BARDMT12X130Defect Measurement Tool (12/13mm)400213BAR-DMT-12X132020-02-04
M906BARDMT6X70Defect Measurement Tool (6/7mm)400210BAR-DMT-6X72020-02-04
M906BARDMT8X90Defect Measurement Tool (8/9mm)400211BAR-DMT-8X92020-02-04
M906BARMALLET0Surgical Mallet (Slotted)400929BAR-MALLET2020-02-04
M906BARWEDGE0Barricaid® ACD Retraction Wedge400846BAR-WEDGE2020-02-04
M906KITD4C10Barricaid® ACD - Reusable Instruments Kit (Tray Only)400885KIT-D4-C12020-02-04
M906KITD40Barricaid® ACD - Reusable Instruments Kit4001004KIT-D42019-05-14
M906DMT10X11A0Defect Measurement Tool (10/11mm)400212DMT-10X11-A2019-05-14
M906DMT12X13A0Defect Measurement Tool (12/13mm)400213DMT-12X13-A2019-05-14