FDA.reportPublic FDA data

MBD Medical, LLC

Primary DI
00852406006403
Brand
MBD Medical, LLC
Company
Mbd Medical LLC
Model
101
Catalog number
101
Device description
SET, CLAVICLE SYSTEM
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852406006403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852406006403008524060064038524060064030852406006403

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
610.954.7901rwisniewski@mbdmedical.com

Regulatory Flags#

DUNS number
079844748
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852406006007MBD Medical, LLC251-10251-102015-10-24
00852406006014MBD Medical, LLC251-12251-122015-10-24
00852406006021MBD Medical, LLC251-14251-142015-10-24
00852406006038MBD Medical, LLC251-16251-162015-10-24
00852406006045MBD Medical, LLC251-18251-182015-10-24
00852406006052MBD Medical, LLC251-20251-202015-10-24
00852406006069MBD Medical, LLC251-22251-222015-10-24
00852406006076MBD Medical, LLC251-24251-242015-10-24
00852406006083MBD Medical, LLC402-12402-122015-10-24
00852406006090MBD Medical, LLC402-14402-142015-10-24
00852406006106MBD Medical, LLC402-16402-162015-10-24
00852406006113MBD Medical, LLC402-18402-182015-10-24
00852406006120MBD Medical, LLC402-20402-202015-10-24
00852406006137MBD Medical, LLC402-22402-222015-10-24
00852406006144MBD Medical, LLC402-24402-242015-10-24
00852406006151MBD Medical, LLC601-06601-062015-10-24
00852406006168MBD Medical, LLC601-07601-072015-10-24
00852406006175MBD Medical, LLC601-08601-082015-10-24
00852406006182MBD Medical, LLC601-09601-092015-10-24
00852406006199MBD Medical, LLC601-10601-102015-10-24

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Primary DI, Brand, Company table
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008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
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