FDA.report

OsteoMed

Primary DI
00845694004459
Brand
OsteoMed
Company
OSTEOMED LLC
Model
216-0306
Catalog number
216-0306
Device description
Activation Wire, 72mm
Published
2016-06-09
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
true

Related Records

Contact Domains

Product Codes

CodeName
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
MQNExternal Mandibular Fixator And/Or DistractorDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694004459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694004459008456940044598456940044590845694004459

GMDN Terms

TermDefinition
Implantable craniofacial bone distractorAn implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.

Device Sizes

TypeValueUnit
Length72Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 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
07613327682717NAStryker Leibinger GmbH & Co. KGMQN2026-02-27
07613327682724NAStryker Leibinger GmbH & Co. KGMQN2026-02-27
00888118145376IPSKLS-Martin L.P.MQN2025-09-24
00888118145383IPSKLS-Martin L.P.MQN2025-09-24
00888118145390IPSKLS-Martin L.P.MQN2025-09-24
00888118148735DISTRACTION, INTERNALKLS-Martin L.P.MQN2025-09-24
00888118143457DISTRACTION, INTERNALKLS-Martin L.P.MQN2025-02-24
00888118139962DISTRACTION, INTERNALKLS-Martin L.P.MQN2023-02-23
00888118129611IPSKLS-Martin L.P.MQN2022-10-21
00888118129628IPSKLS-Martin L.P.MQN2022-10-21
00888118129635IPSKLS-Martin L.P.MQN2022-10-21
00888118129642IPSKLS-Martin L.P.MQN2022-10-21
00888118129659IPSKLS-Martin L.P.MQN2022-10-21
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00888118129673IPSKLS-Martin L.P.MQN2022-10-21
00888118129680IPSKLS-Martin L.P.MQN2022-10-21
00888118129697IPSKLS-Martin L.P.MQN2022-10-21
00888118129703IPSKLS-Martin L.P.MQN2022-10-21
00888118129710IPSKLS-Martin L.P.MQN2022-10-21
00888118129727IPSKLS-Martin L.P.MQN2022-10-21
00888118129734IPSKLS-Martin L.P.MQN2022-10-21
00888118129741IPSKLS-Martin L.P.MQN2022-10-21
00888118129758IPSKLS-Martin L.P.MQN2022-10-21
00888118129765IPSKLS-Martin L.P.MQN2022-10-21
00888118129772IPSKLS-Martin L.P.MQN2022-10-21
00888118129789IPSKLS-Martin L.P.MQN2022-10-21
00888118129796IPSKLS-Martin L.P.MQN2022-10-21
00888118129802IPSKLS-Martin L.P.MQN2022-10-21
00888118129819IPSKLS-Martin L.P.MQN2022-10-21
00888118129826IPSKLS-Martin L.P.MQN2022-10-21