FDA.reportPublic FDA data

n/a

Primary DI
00822409104031
Brand
n/a
Company
Ortho Development Corporation
Model
880-0001
Catalog number
880-0001
Device description
Troch Nail Entry Reamer Sleeve
Published
2022-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXZGuard, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXZGuard, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409104031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409104031008224091040318224091040310822409104031

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)553-9991customerservice@odev.com

Regulatory Flags#

DUNS number
876542390
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
00822409080311N/A228-00312026-05-16
00822409098880N/A853-10512026-05-16
00822409131297N/A853-00722026-05-16
00822409131525N/A267-55052026-05-16
00822409133253N/AC-1857-072026-05-16
00822409133260N/AC-1857-082026-05-16
00822409133277N/AC-1857-092026-05-16
00822409133284N/AC-1857-102026-05-16
00822409133291N/AC-1857-112026-05-16
00822409133307N/AC-1857-122026-05-16
00822409133314N/AC-1857-132026-05-16
00822409133321N/AC-1857-142026-05-16
00822409133338N/AC-1857-162026-05-16
00822409133345N/AC-1857-182026-05-16
00822409133352N/AC-1857-202026-05-16
00822409133369N/AC-1858-072026-05-16
00822409133376N/AC-1858-082026-05-16
00822409133383N/AC-1858-092026-05-16
00822409133390N/AC-1858-102026-05-16
00822409133406N/AC-1858-112026-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770418640Bausch + LombBausch & Lomb IncorporatedLXZ2025-08-18
04262488440044TissueGUARDTissueGUARD GmbHLXZ2025-04-25
04262488440037TissueGUARDTissueGUARD GmbHLXZ2025-04-25
04262488440020TissueGUARDTissueGUARD GmbHLXZ2025-04-24
04262488440013TissueGUARDTissueGUARD GmbHLXZ2025-04-24
10843356102694CYGNUSCYGNUS MEDICAL L.L.C.LXZ2024-12-11
00822409101160N/AOrtho Development CorporationLXZ2023-10-06
B7689188290Buxton BioMedicalBuxton Biomedical IncLXZ2023-07-07
00847399007186MicroAire® Microaire Surgical Instruments LLCLXZ2022-03-30
00847399000798MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399000804MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399003690MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399007001MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-29
107073877920053M™ Attest™3M COMPANYLXZ2021-06-18
107073877920123M™ Attest™3M COMPANYLXZ2021-06-18
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307073874694443M™ Comply™3M COMPANYLXZ2021-06-18
307073874694513M™ Comply™3M COMPANYLXZ2021-06-18
307073874694683M™ Comply™3M COMPANYLXZ2021-06-18
507073877920033M™ Attest™3M COMPANYLXZ2021-06-18
507073877920103M™ Attest™3M COMPANYLXZ2021-06-18
507073877920273M™ Attest™3M COMPANYLXZ2021-06-18
507073874694483M™ Comply™3M COMPANYLXZ2021-06-18
507073874694553M™ Comply™3M COMPANYLXZ2021-06-18
507073874694623M™ Comply™3M COMPANYLXZ2021-06-18
10884527010219DevonCardinal Health, Inc.LXZ2018-06-23