FDA.report

OsteoMed

Primary DI
00845694057158
Brand
OsteoMed
Company
OSTEOMED LLC
Model
220-0822
Catalog number
220-0822
Device description
2.0mm Angled Locking Screw Block, ICON
Published
2016-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JEYPLATE, BONE

Product Code Classifications

CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694057158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694057158008456940571588456940571580845694057158

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)456-7779Customer.Service@osteomed.com

Regulatory Flags

DUNS number
606417780
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
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
00842528129906OsteoMed336-9207336-92072023-10-13
00842528129913OsteoMed336-9208336-92082023-10-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888118149671LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149701LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149718LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149725LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149732LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149749LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149756LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149763LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149770LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149787LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149794LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149800LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149817LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149824LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149831LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149848LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149855LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149879LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149886LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149893LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149909LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149916LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149923LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149930LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149947LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149954LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149961LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149978LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149985LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118153128LEVEL ONE NEURO, STERILEKLS-Martin L.P.JEY2026-03-23