FDA.reportPublic FDA data

Mallet Tip - Teflon

Primary DI
B046BIO110910
Brand
Mallet Tip - Teflon
Company
SIGNAL MEDICAL CORPORATION
Model
Teflon
Catalog number
BIO-1-1091
Device description
Mallet Tip - Teflon
Published
2022-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFJMallet, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFJMallet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B046BIO110910PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical mallet headA device intended to replace the head of some types of surgical mallets and hammers. It is typically a solid cylinder of various diameters with flat ends; it is made of durable, non-splintering, synthetic polymer materials and is fixed (typically screwed using it's central screw thread) to the the distal end of the mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8103647070vfowler@signalmd.com

Regulatory Flags#

DUNS number
169289308
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B046BIO110830PCL RetractorN/ABIO-1-10832023-02-21
B046BIO11081Femoral BeltN/ABIO-1-10812022-06-17
B046BIO11082Tibial BeltN/ABIO-1-10822022-05-12
B046BIO110840Lateral RetractorN/ABIO-1-10842022-05-12
B046BIO110350Gel Pad"46"""BIO-1-10352022-02-10
B046BIO110210Slide BlockBIO-1-1021BIO-1-10212021-10-22
B046BIO110220Boot AssemblyBIO-1-1022BIO-1-10222021-10-22
B046BIO110240End StopBIO-1-1024BIO-1-10242021-10-22
B046BIO11012A0Low Profile Cable1.5mm CableBIO-1-1012-A2021-08-26
B046BIO110120CoCr Low Profile Cable System1.5mm CableBIO110122016-01-12
B046WF110010Cancellous Bone Screw15mmWF-1-10012016-08-05
B046WF110020Cancellous Bone Screw20mmWF-1-10022016-01-07
B046WF110030Cancellous Bone Screw25mmWF-1-10032016-02-12
B046WF110040Cancellous Bone Screw30mmWF-1-10042016-01-07
B046WF110050Cancellous Bone Screw35mmWF-1-10052015-12-16
B046WF110060Cancellous Bone Screws40mmWF-1-10062015-12-16
B046WF110070Cancellous Bone Screw45mmWF-1-10072019-03-22
B046WF110080Cancellous Bone Screw50mmWF-1-10082019-03-22
B046BIO110930Straight Osteotome"1/2"""BIO-1-10932023-04-24
B046BIO110440Knee OsteogatorN/ABIO-1-10442023-03-14

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Primary DI, Brand, Company table
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05055445941246SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941253SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
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05055445941321SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
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05055445941345SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941352SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
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