OsteoMed

Primary DI
00845694011419
Brand
OsteoMed
Company
OSTEOMED LLC
Model
371-0207
Catalog number
371-0207
Device description
Metatarsal Head Trial, Extra Long
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZJPROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-ConstrainedUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845694011419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694011419008456940114198456940114190845694011419

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter19Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0275 Degrees Fahrenheit

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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556828229Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-22
00885556828250Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-22
00885556828281Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-22
00885556828311Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-22
00885556828410Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-21
00885556828441Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-21
00885556828472Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-21
00885556828502Movement Great Toe SystemSmith & Nephew, Inc.LZJ2022-12-21
00880304216860TOTAL TOE SYSTEMBiomet Orthopedics, LLCLZJ2018-12-19
00880304216907TOTAL TOE SYSTEMBiomet Orthopedics, LLCLZJ2018-12-19
00880304216914TOTAL TOE SYSTEMBiomet Orthopedics, LLCLZJ2018-12-19
00880304217003TOTAL TOE SYSTEMBiomet Orthopedics, LLCLZJ2018-12-19
M2480120031KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
M2480120101KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.LZJ2017-10-09
M2480120021KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120041KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120051KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120061KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120071KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120121KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120141KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
M2480120161KGTI™ Kinetik Great Toe Implant SystemINTEGRA LIFESCIENCES CORPORATIONLZJ2017-10-09
00845694014632OsteoMedOSTEOMED LLCLZJ2016-10-14
00845694028516OsteoMedOSTEOMED LLCLZJ2016-10-14
00845694028523OsteoMedOSTEOMED LLCLZJ2016-10-14
00845694036894OsteoMedOSTEOMED LLCLZJ2016-10-14
00845694036900OsteoMedOSTEOMED LLCLZJ2016-10-14
00845694036917OsteoMedOSTEOMED LLCLZJ2016-10-14
00845694036931OsteoMedOSTEOMED LLCLZJ2016-10-14
00845694036962OsteoMedOSTEOMED LLCLZJ2016-10-14