FDA.reportPublic FDA data

Bio-Flek

Primary DI
00763000299101
Brand
Bio-Flek
Company
MEDTRONIC XOMED, INC.
Model
1358225
Device description
HEAD SUPPORT 1358225 BIOFLEK SURGICAL
Published
2021-04-25
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
EPWSupport, head, surgical, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPWSupport, Head, Surgical, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000299101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000299101007630002991017630002991010763000299101

GMDN Terms#

Term, Definition table
TermDefinition
ENT headrestA device designed to be attached to an appropriate operating table to support and stabilize the head of a recumbent patient during an ear/nose/throat (ENT) procedure. The headrest is typically made of metal and synthetic materials that incorporate a cup-shaped, or indented with a central hole, cushion or pad that provides a softer surface for the patient's head to rest in. It is available in various shapes and sizes and will typically include mechanical mechanisms that enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.

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
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
20763000041544NIM TriVantage®82297392020-02-29
00763000033972NIM TriVantage®82297092020-02-15
20681490055158Merocel®22185352017-10-16
00643169782617NIM Trivantage®82297092016-11-12
00613994176547Reuter10103012015-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250381851463Forceps holderSpiggle & Theis Medizintechnik GmbHEPW2025-09-25
04250381862520Solution bowlSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
04250676740007Solution bowlSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
04250676740014Solution bowlSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
04250676740021Metal cupSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
00810075280999Bone FoamBONE FOAM, INC.EPW2022-05-22
00810075281002Bone FoamBONE FOAM, INC.EPW2022-05-22
00810075280104BoneFoamBONE FOAM, INC.EPW2022-05-22
20681490013240N/AMEDTRONIC XOMED, INC.EPW2021-07-04
00681490039017Bio-FlekMEDTRONIC XOMED, INC.EPW2021-07-04
00681490039024Bio-FlekMEDTRONIC XOMED, INC.EPW2021-07-04
00681490013246N/AMEDTRONIC XOMED, INC.EPW2021-07-04
00763000299118Bio-FlekMEDTRONIC XOMED, INC.EPW2021-04-25
00811304020539"Voss 9"" Round Support"VM/POSITIONING, INC.EPW2018-06-11
00821925037731GYRUS ACMI Gyrus ACMI, LLCEPW2015-10-24