FDA.reportPublic FDA data

NA

Primary DI
20681490069322
Brand
NA
Company
MEDTRONIC XOMED, INC.
Model
3118535
Device description
SPIKE 3118535 20PK NON-VENTED IRRIGATION
Published
2016-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K791407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K791407000WOMED NICRO-CRAFT POWER SYSTEMXomed, Inc.1979-08-22ERL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20681490069322PackageGS120In Commercial Distribution
00681490069328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068149006932220681490069322
00681490069328006814900693286814900693280681490069328

GMDN Terms#

Term, Definition table
TermDefinition
Needle styletA device made of a thin wire or thin flexible rod that is intended to be inserted into the lumen of a needle to render it stiff and maintain the shape or patency of the needle, or to clear the lumen of the needle. It is available in various wire lengths and diameters, and will typically have a plastic knob at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
835465063
Device count
20
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
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHERL2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHERL2025-12-18
J021305000001Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHERL2025-07-08
J021305010001Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHERL2025-07-08
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAERL2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAERL2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAERL2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAERL2025-03-20
J021304680001S-10 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2024-02-07
J021304700001S-12 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2024-02-07
J021303870021SpeedControl SC1 (M-UK1023)W & H Dentalwerk Bürmoos GmbHERL2023-10-12
J021303880021SpeedControl SC1 (M-UK1015)W & H Dentalwerk Bürmoos GmbHERL2023-10-12
J021303930011M-MH40 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2023-10-12
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAERL2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAERL2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAERL2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAERL2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAERL2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAERL2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAERL2023-02-22
07630055507853Cable for HS-Micro-Motor,largeBien-Air Surgery SAERL2023-02-22
07630055507860Perforator MotorBien-Air Surgery SAERL2023-02-22
07630055505507ShBlade Straight Ø3.0 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505514ShBlade Straight Ø3.5 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505521ShBlade Straight Ø4.0 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505026BASCH MicromotorBien-Air Surgery SAERL2023-02-10
07630055505828BASCH-1 MicromotorBien-Air Surgery SAERL2023-02-10