FDA.reportPublic FDA data

Diego Elite

Primary DI
00821925036796
Brand
Diego Elite
Company
Gyrus ACMI, LLC
Model
MBUR5060DVC
Device description
BURR, 5MM, DIAMOND CRSE 10-25MM VAR EXPOSURE Diego Elite Drill
Published
2018-09-14
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

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
00821925036796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925036796008219250367968219250367960821925036796

GMDN Terms#

Term, Definition table
TermDefinition
Diamond ENT bur, single-useA rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925032774Gyrus ACMI145011-ENT2016-09-29
00821925032859Gyrus ACMI145007-ENT2016-09-29
00821925032903Gyrus ACMI145216-ENT2016-09-29
00821925034044Gyrus ACMI2220-2210-052016-10-11
00821925034853Gyrus ACMI7089-08442018-09-13
00821925034860Gyrus ACMI7089-08462018-09-13
00821925034877Gyrus ACMI7089-08482018-09-13
00821925034884Gyrus ACMI7089-08502018-09-13
00821925034891Gyrus ACMI7089-08522018-09-13
00821925034907Gyrus ACMI7089-08542018-09-13
00821925034938Gyrus ACMI7089-08362018-09-13
00821925034945Gyrus ACMI7089-08382018-09-13
00821925034969Gyrus ACMI7089-08422018-09-13
00821925035072Gyrus ACMI145010-ENT2015-10-24
00821925036383Gyrus ACMIE-9F2016-10-13
00821925037915GYRUS ACMI004942-9012016-10-07
00821925037960Gyrus ACMI1010-2110-052016-10-07
00821925037977Gyrus ACMI1120-4110-052016-10-07
00821925038325Gyrus ACMICS-G52016-10-13
00821925038349Gyrus ACMIE-1F2016-10-13

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