FDA.reportPublic FDA data

PECTUS BLU (TM)

Primary DI
00888233028837
Brand
PECTUS BLU (TM)
Company
BIOMET MICROFIXATION, INC
Model
78-0040
Catalog number
78-0040
Published
2022-02-09
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
false

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212841000
K261002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212841000Pectus Blu Support Bar SystemBiomet Micofixation2022-01-07HRS
K261002000Pectus Blu SystemBiomet Microfixation2026-06-02HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233028837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233028837008882330288378882330288370888233028837

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
046189866
Device count
1
DM exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036020811Mimix QS02-11052015-09-11
00841036020828Mimix QS02-11102015-09-11
00841036020965MIMIX02-20052015-09-11
00841036020996MIMIX02-20102015-09-11
00841036021009MIMIX02-20252015-09-11
00841036141943OTOMIMIX7014-32662015-09-11
00888233025140N/A02-290202-29022020-06-26
00888233025157N/A02-290502-29052020-06-26
00888233025164N/A02-310102-31012020-06-26
00888233025171N/A02-310202-31022020-06-26
00888233025188N/A02-310502-31052020-06-26
00888233025195N/A02-311002-31102020-06-26
00888233025201N/A7014-32667014-32662020-06-26
00841036125844ALLOGENIX02-31012015-09-24
00841036125851ALLOGENIX02-31022015-09-24
00841036125868ALLOGENIX02-31052015-09-24
00841036125875ALLOGENIX02-31102015-09-24
00841036181468ALLOGENIX PLUS02-29022015-09-24
00841036181475ALLOGENIX PLUS02-29052015-09-24
00841036019112N/A02-008302-00832017-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986485137CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485144CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485151CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485168CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485274CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485281CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485298CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485304CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485311CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485328CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485335CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485342CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485359CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485366CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485373CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485380CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485397CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485403CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485410CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485427CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485434CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485441CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485458CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485465CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485472CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485588CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485595CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485601CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485618CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485625CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29