FDA.reportPublic FDA data

Tools - Screws

Primary DI
00842188112485
Brand
Tools - Screws
Company
Trimed, INC.
Model
GUIDE-3.2/4.0
Catalog number
GUIDE-3.2/4.0
Device description
Drill Guide, 3.2mm/4.0mm
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188112485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188112485008421881124858421881124850842188112485

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327007114ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-25
07613327007558XIA 3Stryker CorporationLXH2019-11-25
07613327007565XIA 3Stryker CorporationLXH2019-11-25
07613327114881XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327121919XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327126273AVS Anchor-C Cervical Cage SystemStryker CorporationLXH2019-11-25
07613327142662XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327142679XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327177480OASYSStryker CorporationLXH2019-11-25
07613327261752DIAPASONStryker CorporationLXH2019-11-25
07613327261943O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261950O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261967O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261974O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261998O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262001O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262018O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262025O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262032O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262049O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262056O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262070O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262087O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262094O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262100CENTAURStryker CorporationLXH2019-11-25
07613327262285XIAStryker CorporationLXH2019-11-25
07613327263176XIA IIStryker CorporationLXH2019-11-25
07613327263183XIA IIStryker CorporationLXH2019-11-25
07613327263190XIA IIStryker CorporationLXH2019-11-25
07613327263220XIA IIStryker CorporationLXH2019-11-25