FDA.reportPublic FDA data

Oto-Flex

Primary DI
00763000035884
Brand
Oto-Flex
Company
MEDTRONIC XOMED, INC.
Model
3155621
Device description
KNIFE 3155621 OTO-FLEX 2.3MM DIAMOND
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
00763000035884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000035884007630000358847630000358840763000035884

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal knifeA hand-held manual surgical instrument designed to cut and dissect laryngeal tissue, including the vocal cords, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and available in various shapes (e.g., sickle, flap, straight) according to the procedure performed (e.g., excision of cysts, adhesions, webs). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.3Millimeter

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
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
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 SAERL2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAERL2023-02-22
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