FDA.reportPublic FDA data

NA

Primary DI
20886982198652
Brand
NA
Company
Synthes GmbH
Model
392.179
Catalog number
392179
Device description
PROTECTIVE CAPS FOR 2.0MM KIRSCHNER WIRES
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
HRSPLATE, FIXATION, BONE
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
MQNExternal Mandibular Fixator And/Or DistractorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001941000
K050378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001941000SYNTHES MODULAR FOOT SYSTEMSynthes (Usa)2000-09-22HRS
K050378000SYNTHES MANDIBLE EXTERNAL FIXATORSynthes (Usa)2005-03-15MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886982198652PrimaryGS10
H6793921790SecondaryHIBCC0
80886982198654Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088698219865220886982198652
8088698219865480886982198654

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
10
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112592986TriLEAP04.901.022049010222024-02-22
00810112592993TriLEAP04.901.024049010242024-02-22
00810112593006TriLEAP04.901.026049010262024-02-22
00810112593013TriLEAP04.901.028049010282024-02-22
00810112593020TriLEAP04.901.030049010302024-02-22
00810112593037TriLEAP04.902.008049020082024-02-22
00810112593044TriLEAP04.902.009049020092024-02-22
00810112593051TriLEAP04.902.010049020102024-02-22
00810112593068TriLEAP04.902.011049020112024-02-22
00810112593075TriLEAP04.902.012049020122024-02-22
00810112593082TriLEAP04.902.013049020132024-02-22
00810112593099TriLEAP04.902.014049020142024-02-22
00810112593105TriLEAP04.902.015049020152024-02-22
00810112593112TriLEAP04.902.016049020162024-02-22
00810112593129TriLEAP04.902.018049020182024-02-22
00810112593136TriLEAP04.902.020049020202024-02-22
00810112593143TriLEAP04.902.022049020222024-02-22
00810112593150TriLEAP04.902.024049020242024-02-22
00810112593167TriLEAP04.902.026049020262024-02-22
00810112593174TriLEAP04.902.028049020282024-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112592245TriLEAPSynthes GmbHHRS2024-02-23
00810112592252TriLEAPSynthes GmbHHRS2024-02-23
00810112592429TriLEAPSynthes GmbHHRS2024-02-23
00810112592450TriLEAPSynthes GmbHHRS2024-02-23
00810112592467TriLEAPSynthes GmbHHRS2024-02-23
00810112592474TriLEAPSynthes GmbHHRS2024-02-23
00810112592634TriLEAPSynthes GmbHHRS2024-02-23
00810112592832TriLEAPSynthes GmbHHRS2024-02-23
00810112592849TriLEAPSynthes GmbHHRS2024-02-23
00810112592986TriLEAPSynthes GmbHHRS2024-02-22
00810112592993TriLEAPSynthes GmbHHRS2024-02-22
00810112593006TriLEAPSynthes GmbHHRS2024-02-22
00810112593013TriLEAPSynthes GmbHHRS2024-02-22
00810112593020TriLEAPSynthes GmbHHRS2024-02-22
00810112593037TriLEAPSynthes GmbHHRS2024-02-22
00810112593044TriLEAPSynthes GmbHHRS2024-02-22
00810112593051TriLEAPSynthes GmbHHRS2024-02-22
00810112593068TriLEAPSynthes GmbHHRS2024-02-22
00810112593075TriLEAPSynthes GmbHHRS2024-02-22
00810112593082TriLEAPSynthes GmbHHRS2024-02-22
00810112593099TriLEAPSynthes GmbHHRS2024-02-22
00810112593105TriLEAPSynthes GmbHHRS2024-02-22
00810112593112TriLEAPSynthes GmbHHRS2024-02-22
00810112593129TriLEAPSynthes GmbHHRS2024-02-22
00810112593136TriLEAPSynthes GmbHHRS2024-02-22
00810112593143TriLEAPSynthes GmbHHRS2024-02-22
00810112593150TriLEAPSynthes GmbHHRS2024-02-22
00810112593167TriLEAPSynthes GmbHHRS2024-02-22
00810112593174TriLEAPSynthes GmbHHRS2024-02-22
00810112593181TriLEAPSynthes GmbHHRS2024-02-22