FDA.report

Malleolus Implant Drill Bit

Primary DI
00810028391673
Brand
Malleolus Implant Drill Bit
Company
Trilliant Surgical, LLC
Model
340-45-001
Published
2022-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HTWBit, Drill

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810028391673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028391673008100283916738100283916730810028391673

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
828829072
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

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00190446898795Stabilization330-00-0112025-07-01
00190446898818Stabilization330-27-0162025-07-01
00190446898825Stabilization330-35-0162025-07-01
00190446898832Stabilization330-00-0172025-07-01
00190446910091Stabilization330-01-3012025-07-01
00190446910459Stabilization330-01-3022025-07-01
00190446910466Stabilization330-01-3032025-07-01
00190446910473Stabilization330-01-3042025-07-01
00190446910480Stabilization330-01-3052025-07-01
00190446910497Stabilization330-01-3072025-07-01
00190446910503Stabilization330-01-3082025-07-01
00810028395800Arsenal Reloaded330-01-2142025-04-03
00810028395817Arsenal Reloaded330-01-2122025-04-03
00810028395824Arsenal Reloaded 330-01-2112025-04-03
00810028395831Arsenal Reloaded 330-01-2132025-04-03
00190446898269Stabilization340-01-2072024-12-18

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