FDA.reportPublic FDA data

Paul Banditt

Primary DI
D955PARTNYLON1
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
PARTNYLON
Device description
"PAUL BANDITT, NYLON REPLACEMENT TIPS FOR "" NYLON"" MALLET, Per pair"
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D955PARTNYLON1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
177465051
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D95516CASS1Paul Banditt16CASS2026-09-25
D9555CASS1Paul Banditt5CASS2026-09-25
D9558CASS1Paul Banditt8CASS2026-09-25
D955BBCG35450Paul BandittBBCG35452026-09-25
D955BBGA351Paul BandittBBGA352026-09-25
D955BBGA451Paul BandittBBGA452026-09-25
D955BBGA551Paul BandittBBGA552026-09-25
D955BBGA701Paul BandittBBGA702026-09-25
D955BDT11Paul BandittBDT12026-09-25
D955BDT21Paul BandittBDT22026-09-25
D955BDT31Paul BandittBDT32026-09-25
D955BDT61Paul BandittBDT62026-09-25
D955BDT71Paul BandittBDT72026-09-25
D955BDT81Paul BandittBDT82026-09-25
D955BDT91Paul BandittBDT92026-09-25
D955BLAHST1Paul BandittBLAHST2026-09-25
D955BMDG010Paul BandittBMDG-012026-09-25
D955BMDG021Paul BandittBMDG-022026-09-25
D955BMDG031Paul BandittBMDG-032026-09-25
D955BONDNG1Paul BandittBONDNG2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423582MillenniumAvalign Technologies, Inc.GFJ2026-08-07
00190776423599MillenniumAvalign Technologies, Inc.GFJ2026-08-07
G22315466860Medetz Surgical InstrumentsMedetz Surgical Instruments LLCGFJ2026-07-27
G149TBSB71200TBS BASICSACME ENTERPRISE.GFJ2026-05-22
05055445941086SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941093SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941109SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941116SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941123SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941130SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941147SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941154SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941161SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941178SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941185SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941192SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941208SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941215SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941222SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941239SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941246SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941253SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941260SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941277SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941284SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941291SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941307SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941314SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941321SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941338SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12