FDA.report

Solid-Core Removal Tool

Primary DI
00810028391697
Brand
Solid-Core Removal Tool
Company
Trilliant Surgical, LLC
Model
340-15-007
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
false

Related Records

Product Codes

CodeName
HWBExtractor

Product Code Classifications

CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810028391697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028391697008100283916978100283916970810028391697

GMDN Terms

TermDefinition
Screw extractor, reusableA hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. 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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00190446910459Stabilization330-01-3022025-07-01
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00190446910473Stabilization330-01-3042025-07-01
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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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