FDA.reportPublic FDA data

Oto-Flex

Primary DI
00763000035907
Brand
Oto-Flex
Company
MEDTRONIC XOMED, INC.
Model
3155625
Device description
PERFORATOR 3155625 OTO-FLEX .5MM
Published
2021-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EQJBUR, EAR, NOSE AND THROAT
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000035907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000035907007630000359077630000359070763000035907

GMDN Terms#

Term, Definition table
TermDefinition
Metal/carbide ENT bur, reusableA small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.5Millimeter

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

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
Sterilization required before use
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
07613327576801PELLOSTRYKER CORPORATIONEQJ2024-11-13
07613327576825PELLOSTRYKER CORPORATIONEQJ2024-11-13
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAERL2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAERL2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAERL2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAERL2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAEQJ2023-02-22
07630055506542HS Diam. Burr, Ø0.6x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506559HS Diam. Burr, Ø0.8x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506566HS Diam. Burr, Ø1.0x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506573HS Diam. Burr, Ø1.4x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506580HS Diam. Burr, Ø1.8x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506597HS Diam. Burr, Ø2.3x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506603HS Diam. Burr, Ø2.7x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506610HS Diam. Burr, Ø3.1x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506627HS Diam. Burr, Ø3.5x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506634HS Diam. Burr, Ø4.0x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506641HS Diam. Burr, Ø5.0x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506658HS Diam. Burr, Ø6.0x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506665HS Diam. Burr, Ø7.0x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506672Tungst.Carb.Burr,Ø0.5x70mm,50kBien-Air Surgery SAEQJ2023-02-22