FDA.reportPublic FDA data

OsteoMed

Primary DI
00845694058629
Brand
OsteoMed
Company
OSTEOMED LLC
Model
220-0640-18
Catalog number
220-0640-18
Device description
210-0040, Blue ID Tag, CHIN 4mm
Published
2016-07-22
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
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845694058629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694058629008456940586298456940586290845694058629

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)456-7779Customer.Service@osteomed.com

Regulatory Flags#

DUNS number
606417780
Device count
1
DM 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
00845694011815OsteoMed375-0008375-00082016-07-21
00845694041546OsteoMed320-2701320-27012016-07-21
00842528129722OsteoMed336-9101336-91012023-10-13
00842528129739OsteoMed336-9102336-91022023-10-13
00842528129746OsteoMed336-9103336-91032023-10-13
00842528129753OsteoMed336-9104336-91042023-10-13
00842528129760OsteoMed336-9105336-91052023-10-13
00842528129777OsteoMed336-9106336-91062023-10-13
00842528129784OsteoMed336-9107336-91072023-10-13
00842528129791OsteoMed336-9108336-91082023-10-13
00842528129807OsteoMed336-9109336-91092023-10-13
00842528129814OsteoMed336-9110336-91102023-10-13
00842528129821OsteoMed336-9111336-91112023-10-13
00842528129838OsteoMed336-9112336-91122023-10-13
00842528129845OsteoMed336-9201336-92012023-10-13
00842528129852OsteoMed336-9202336-92022023-10-13
00842528129869OsteoMed336-9203336-92032023-10-13
00842528129876OsteoMed336-9204336-92042023-10-13
00842528129883OsteoMed336-9205336-92052023-10-13
00842528129890OsteoMed336-9206336-92062023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
00888118126528LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2020-04-22
10888118113600LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
10888118113617LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
00888118001825LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118001870LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118002129LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118002136LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003041LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003058LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003751LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003775LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003782LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003799LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003805LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003935LEVEL ONE NEUROKLS-Martin L.P.JEY2016-03-24
00888118003942LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003959LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118004840LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005298LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005304LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005311LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005441LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005458LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005571LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005588LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24