FDA.report

OsteoMed

Primary DI
00845694032780
Brand
OsteoMed
Company
OSTEOMED LLC
Model
217-1260
Catalog number
217-1260
Device description
Oracle Organizer Block
Published
2016-07-25
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
PBJCranial Distraction System

Product Code Classifications

CodeDeviceSpecialtyClass
PBJCranial Distraction SystemNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694032780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694032780008456940327808456940327800845694032780

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.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0275 Degrees Fahrenheit

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
00888118149367DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2025-09-24
00888118136589DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136596DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136626DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136633DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
00888118136640DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
00888118136657DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
H98004315852010NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315784010NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315788010NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315792010NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315806010NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315824050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315832050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315786050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315788050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315790050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315804050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315846050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315850050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315808050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315810050NASYNTHES (U.S.A.) LPPBJ2019-12-12
00842528123300OsteoMedOSTEOMED LLCPBJ2019-11-08
00842528123317OsteoMedOSTEOMED LLCPBJ2019-11-08
00888118114310DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12
00888118114464DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12
00888118114471DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12
00888118114488DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12
00888118114495DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12
00888118114501DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12