FDA.reportPublic FDA data

NA

Primary DI
10887587015156
Brand
NA
Company
Synthes GmbH
Model
04.305.100
Catalog number
04305100
Device description
4.0MM TI PRE-BENT ROD/FULL MANDIBLE WITH RAMUS
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040169000SYNTHES MANDIBLE EXTERNAL FIXATORSynthes (Usa)2004-04-14MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587015156PrimaryGS10
H980043051000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758701515610887587015156

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system noninvasive component, single-useA noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982199539NASynthes GmbHMQN2015-09-14
10886982199560NASynthes GmbHMQN2015-09-14
10886982200419NASynthes GmbHMQN2015-09-14
10886982200426NASynthes GmbHMQN2015-09-14
10886982200433NASynthes GmbHMQN2015-09-14
10886982203502NASynthes GmbHMQN2015-09-14
10886982203519NASynthes GmbHMQN2015-09-14
10886982203526NASynthes GmbHMQN2015-09-14
10886982203533NASynthes GmbHMQN2015-09-14
10886982203540NASynthes GmbHMQN2015-09-14
10886982203557NASynthes GmbHMQN2015-09-14
10886982203564NASynthes GmbHMQN2015-09-14
10886982203571NASynthes GmbHMQN2015-09-14
10886982203588NASynthes GmbHMQN2015-09-14
10886982203595NASynthes GmbHMQN2015-09-14
10886982203601NASynthes GmbHMQN2015-09-14
10886982203618NASynthes GmbHMQN2015-09-14
10886982203625NASynthes GmbHMQN2015-09-14
10886982203632NASynthes GmbHMQN2015-09-14
10886982203649NASynthes GmbHMQN2015-09-14
10886982203656NASynthes GmbHMQN2015-09-14
10886982203663NASynthes GmbHMQN2015-09-14
10886982203670NASynthes GmbHMQN2015-09-14
10886982203687NASynthes GmbHMQN2015-09-14
10886982203694NASynthes GmbHMQN2015-09-14
10886982203700NASynthes GmbHMQN2015-09-14
10886982203717NASynthes GmbHMQN2015-09-14
10886982203724NASynthes GmbHMQN2015-09-14
10886982203731NASynthes GmbHMQN2015-09-14
10886982203748NASynthes GmbHMQN2015-09-14