FDA.reportPublic FDA data

Brackmann / Polycel®

Primary DI
00763000035389
Brand
Brackmann / Polycel®
Company
MEDTRONIC XOMED, INC.
Model
1156303
Device description
PROSTHESIS 1156303 BRACKMANN TOTAL
Published
2021-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBNREPLACEMENT, TOTAL OSSICULAR, PROSTHESIS, POROUS, POLYETHYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBNReplacement, Total Ossicular, Prosthesis, Porous, PolyethyleneEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822367000TOTALTreace Medical, Inc.1982-09-07LBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000035389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000035389007630000353897630000353890763000035389

GMDN Terms#

Term, Definition table
TermDefinition
Ossicular prosthesis, totalA sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of polymers.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000821777NIM EssenceNIMEID0602026-06-07
00763000821784NIM EssenceNIMEID0652026-06-07
00763000821791NIM EssenceNIMEID0702026-06-07
00763000821807NIM EssenceNIMEID0752026-06-07
00763000821814NIM EssenceNIMEID0802026-06-07
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000913687Brackmann/PolycelMEDTRONIC XOMED, INC.LBN2025-06-23
00763000035372Moretz / Polycel®MEDTRONIC XOMED, INC.LBN2021-11-07
00681490035408Fischer Sprandel IIMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035415MortezMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035422MortezMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035439MortezMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035446MortezMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035453BrackmannMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035460MoretzMEDTRONIC XOMED, INC.LBN2015-07-01