FDA.reportPublic FDA data

N/A

Primary DI
00763000036706
Brand
N/A
Company
MEDTRONIC XOMED, INC.
Model
1884501
Device description
DRILL BIT 1884501 MAX TREPHINE 5MM
Published
2020-02-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EQJBUR, EAR, NOSE AND THROAT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000036706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000036706007630000367067630000367060763000036706

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000888989Merocel4005152026-03-08
20763000888996Merocel4404122026-03-08
00763000892951M41898200T2026-02-28
00199150023851N/A8225101E2026-02-16
00199150023868N/A82251012026-02-16
00199150023875N/A82251102026-02-16
00199150023882N/A82251032026-02-16
00763000548797Hydrodebrider19140012026-02-14
00763000548803Hydrodebrider19210022026-02-14
20763000888910Merocel4001512026-02-15
20763000888927Merocel4001522026-02-15
00763000956028Tubing Set3318604E2026-02-14
00763000945671ApexCut187BL40002026-02-05
00763000945725ApexCut187BL40122026-02-05
00763000945749ApexCut187BL40402026-02-05
00643169547087NIM®82534022025-09-13
00763000745080NuVent™18INFKIT2025-08-15
00763000831479NIM™NIMDTP352025-08-11
20763000831480NIM™8225490X2025-08-11
20763000831497NIM™8225825X2025-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904461030892OSSEOUS- Shaver Blade Tube EON MEDITECH PRIVATE LIMITEDEQJ2026-03-13
17630055519419Bur PM2-70 80K steel Ø1.5 StBien-Air Surgery SAEQJ2026-02-16
17630055519525Bur PM2-70 80K diam EC Ø4.0x80 StBien-Air Surgery SAEQJ2026-02-16
27630055519539Bur PM2-70 80K steel Ø2.0 StBien-Air Surgery SAEQJ2026-02-16
17630055519549Bur PM2-70 80K steel Ø2.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519556Bur PM2-70 80K diam Ø1.5 StBien-Air Surgery SAEQJ2026-02-16
17630055519563Bur PM2-70 80K diam Ø1.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519570Bur PM2-70 80K diam EC Ø5.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519587Bur PM2-70 80K diamC Ø2.0 StBien-Air Surgery SAEQJ2026-02-16
27630055519591Bur PM2-70 80K steel Ø2.5 StBien-Air Surgery SAEQJ2026-02-16
17630055519600Bur PM2-70 80K steel Ø2.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519617Bur PM2-70 80K diamC Ø2.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519624Bur PM2-70 80K diamC Ø2.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519631Bur PM2-70 80K diamC Ø3.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519648Bur PM2-70 80K diamC Ø3.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519655Bur PM2-70 80K diam Ø2.0 StBien-Air Surgery SAEQJ2026-02-16
17630055519662Bur PM2-70 80K diam Ø2.0x80 StBien-Air Surgery SAEQJ2026-02-16
27630055519676Bur PM2-70 80K steel Ø3.0 StBien-Air Surgery SAEQJ2026-02-16
17630055519686Bur PM2-70 80K steel Ø3x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519693Bur PM2-70 80K diamC Ø2.5 StBien-Air Surgery SAEQJ2026-02-16
17630055519709Bur PM2-70 80K diamC Ø4.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519716Bur PM2-70 80K diamC Ø5.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519723Bur PM2-70 80K diamC Ø3.0 StBien-Air Surgery SAEQJ2026-02-16
17630055519730Bur PM2-70 80K diam Ø2.5 StBien-Air Surgery SAEQJ2026-02-16
17630055519747Bur PM2-70 80K diam Ø2.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519754Bur PM2-70 80K diam Ø3.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519761Bur PM2-70 80K diam Ø3.0 StBien-Air Surgery SAEQJ2026-02-16
17630055519778Bur PM2-70 80K FC Ø0.5x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519785Bur PM2-70 80K FC Ø1.0x80 StBien-Air Surgery SAEQJ2026-02-16
17630055519792Bur PM2-70 80K FC Ø1.5x80 StBien-Air Surgery SAEQJ2026-02-16