FDA.reportPublic FDA data

OsteoMed

Primary DI
00845694004275
Brand
OsteoMed
Company
OSTEOMED LLC
Model
216-0000
Catalog number
216-0000
Device description
Logic Distraction Organizer Block
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
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQNExternal Mandibular Fixator And/Or DistractorDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845694004275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694004275008456940042758456940042750845694004275

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.

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
00888118153746DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153753DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153777DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153784DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153807DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153814DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153838DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153845DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153869DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153876DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153890DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153906DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153920DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153937DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153951DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153968DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153982DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153999DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153767DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153798DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153828DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153859DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153880DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153910DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153941DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153972DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118154009DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
07613327682717NAStryker Leibinger GmbH & Co. KGMQN2026-02-27
07613327682724NAStryker Leibinger GmbH & Co. KGMQN2026-02-27
00888118145376IPSKLS-Martin L.P.MQN2025-09-24