FDA.reportPublic FDA data

Tools - CFS

Primary DI
00842188110740
Brand
Tools - CFS
Company
Trimed, INC.
Model
DRILL-2.3/18 STP
Catalog number
DRILL-2.3/18 STP
Device description
Drill 2.3mm, 18mm, STOP
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBIT, DRILL
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188110740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188110740008421881107408421881107400842188110740

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-use, non-sterileA non-sterile 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, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)255-7406info@trimedortho.com

Regulatory Flags#

DUNS number
138041277
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842188131288Tools-WFSWFS-CAB3.8WFS-CAB3.82026-05-13
00842188131172Tools - EFSGDOSLEDW-2.3-WGDOSLEDW-2.3-W2026-02-19
00842188131127Tools - WS3WS3-LONGPLATEWS3-LONGPLATE2026-01-28
00842188131134Tools - WS3WS3-LONGPLATE-LIDWS3-LONGPLATE-LID2026-01-28
00842188129773Tools - AFSAFS-HEX3.2CAFS-HEX3.2C2025-07-22
00842188132469Tools- WS3HNDL-TRQ14HNDL-TRQ142026-03-25
00842188131158SledsOSN-W-50OSN-W-502026-02-19
00842188131165SledsOSN-W-70OSN-W-702026-02-19
00842188130564Volar Bearing PlatesVBEAR-13-7SVBEAR-13-7S2026-01-28
00842188110207Generic InstrumentsIMPCT-SLEDIMPCT-SLED2016-09-07
00842188110214Generic InstrumentsSLED-IMPACTRSLED-IMPACTR2016-09-07
00842188111327Tools - FMSIMPCT-FMSIMPCT-FMS2016-09-07
00842188111334Tools - FMSMINI-IMPACTRMINI-IMPACTR2016-09-07
00842188113185Tools - TSSIMPCT-STPLIMPCT-STPL2016-09-07
00842188113192Tools - TSSSTPL-IMPACTRSTPL-IMPACTR2016-09-07
00842188113383Tools - WFSIMPCTIMPCT2016-09-07
00842188113390Tools - WFSIMPACTRIMPACTR2016-09-07
00842188113635Tools - WFSIMPCT-WHVIMPCT-WHV2016-09-07
00842188113642Tools - WFSWHV-IMPACTRWHV-IMPACTR2016-09-07
00842188113659Tools - WFSIMPCT-WHDIMPCT-WHD2016-09-07

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