FDA.report

Drills

Primary DI
00842188109478
Brand
Drills
Company
TRIMED, INCORPORATED
Model
DRILL-1.4/100
Catalog number
DRILL-1.4/100
Device description
Drill 1.4, 100mm
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HTWBIT, DRILL
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842188109478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188109478008421881094788421881094780842188109478

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(661)255-7406info@trimedortho.com

Regulatory Flags

DUNS number
138041277
Device count
1
DM exempt
true
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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00842188127700Foot PlatesTN-7TN-72024-04-24
00842188127717Foot PlatesTN-7LTN-7L2024-04-24
00842188127724Foot PlatesTN-7STN-7S2024-04-24
00842188127731Foot PlatesMCFL-12MCFL-122024-04-24
00842188127748Foot PlatesMCFL-12LMCFL-12L2024-04-24
00842188127755Foot PlatesMCFR-12MCFR-122024-04-24
00842188127762Foot PlatesMCFR-12LMCFR-12L2024-04-24
00842188127779Foot PlatesMCFL-17MCFL-172024-04-24
00842188127786Foot PlatesMCFL-17LMCFL-17L2024-04-24
00842188127793Foot PlatesMCFR-17MCFR-172024-04-24
00842188127809Foot PlatesMCFR-17LMCFR-17L2024-04-24
00842188127915Foot PlatesMOPL-4LMOPL-4L2024-04-24

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