04315023

GUDID H980043150230

BC DISTRACTOR BODY END ACT. 15MM FOR CMF DISTRACTOR

SYNTHES (U.S.A.) LP

Implantable craniofacial bone distractor
Primary Device IDH980043150230
NIH Device Record Keye9ef9c5b-1ab2-4e32-8c8a-e4630708ccae
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.315.023
Catalog Number04315023
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587015439 [Primary]
HIBCCH980043150230 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


[H980043150230]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-13
Device Publish Date2015-09-14

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10886982293268 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25
10886982293275 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25
10886982293282 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25
10886982293299 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25

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