FDA.reportPublic FDA data

Drill Guide Removal Instrument

Primary DI
00810111220378
Brand
Drill Guide Removal Instrument
Company
TREACE MEDICAL CONCEPTS, INC.
Model
1405-2547
Device description
Drill Guide Removal Instrument
Published
2022-09-12
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

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810111220378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111220378008101112203788101112203780810111220378

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054808082
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111225489Instrument Tray02-004622026-03-23
00810111226745Instrument Tray02-005212026-03-23
00810111227148K-Wire02-004732026-03-23
00810111225649Depth Gage02-004502026-03-19
00810111225601Reamer02-004192026-03-02
00810111225618Reamer02-004182026-03-02
00810111225625Reamer02-004172026-03-02
00810111226691Positioner / Compressor02-005152026-02-20
00810111225366Saw BladeSN442026-01-26
00810111225236Lapiplasty SpeedPlate - TMTSK682026-01-23
00810111225397Guide02-004232026-01-23
00810111225403Guide02-004222026-01-23
00810111225472Drill Guide02-004802026-01-23
00810111225342Saw Blade02-003682026-01-07
00810111226677Positioner / Compressor02-005132026-01-05
00810111226684Positioner / Compressor02-005142026-01-05
00810111226707Positioner / Compressor02-005162026-01-05
00810111225335Saw Blade02-003672025-12-18
00810111224918TMC FastPitch ScrewsSD312025-12-12
00810111225175TMC SpeedTMT02-004022025-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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