FDA.reportPublic FDA data

OsteoMed

Primary DI
00845694037662
Brand
OsteoMed
Company
OSTEOMED LLC
Model
800-1204
Catalog number
800-1204
Device description
PrimaLOK FF Guide Wire Stiffener
Published
2016-07-25
Public version status
Update
Distribution status
Not 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
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845694037662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694037662008456940376628456940376620845694037662

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
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
00081013188039 ION AO Coupling Cannulated Handle SURGENTEC, LLCMRW2026-03-09
00810131880330T-Handle 3/16" ConnectionSURGENTEC, LLCMRW2026-03-09
00810131881252 6.5/7.0 Drill BitSURGENTEC, LLCMRW2026-03-09
00810131881726ION Facet Screw SystemSURGENTEC, LLCMRW2026-03-09
00810131881788ION Cervical Disposable Instrument KitSURGENTEC, LLCMRW2026-03-09
00810131881795ION Disposable Instrument KitSURGENTEC, LLCMRW2026-03-09
00810131881801ION 55 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881818ION 60 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881825ION 65 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881832 7.5 Drill BitSURGENTEC, LLCMRW2026-03-09
00810131881856ION Metal Drill Guide - LargeSURGENTEC, LLCMRW2026-03-09
00810131881986 ION Caddy with Metal PlateSURGENTEC, LLCMRW2026-03-09
00810131882051 Facet Locator - LargeSURGENTEC, LLCMRW2026-03-09
00810131882068 Impactor LargeSURGENTEC, LLCMRW2026-03-09
00810131882075Serrated Rasp - LargeSURGENTEC, LLCMRW2026-03-09
00810131882174ION Large TraySURGENTEC, LLCMRW2026-03-09
00810131882402 6.0mm Drill BitSURGENTEC, LLCMRW2026-03-09
00810131882419Plastic Removal Sleeve - Standard - 7.0-7.5SURGENTEC, LLCMRW2026-03-09
00810131882426Plastic Removal Sleeve - Standard - 5.5-6.5SURGENTEC, LLCMRW2026-03-09
00810131882723ION Cervical TraySURGENTEC, LLCMRW2026-03-09
00810131882747ION Lumbar TraySURGENTEC, LLCMRW2026-03-09
00810131882754ION Facet Screw SystemSURGENTEC, LLCMRW2026-03-09
03760418040667FFX Screw SC MEDICAMRW2025-11-26
03760418040674FFX Screw SC MEDICAMRW2025-11-26
03760418040681FFX Screw SC MEDICAMRW2025-11-26
03760418040698FFX Screw SC MEDICAMRW2025-11-26
03760418040704FFX Screw SC MEDICAMRW2025-11-26
03760418040711FFX Screw SC MEDICAMRW2025-11-26
03760418040728FFX Screw SC MEDICAMRW2025-11-26
03760418040735FFX Screw SC MEDICAMRW2025-11-26