FDA.report

OSSEOUS Burs-Fine Diamond

Primary DI
08904461001670
Brand
OSSEOUS Burs-Fine Diamond
Company
EON MEDITECH PRIVATE LIMITED
Model
EI2120FD
Device description
Burs-Fine Diamond are designed for giving the flexibility to treat a wide range of ENT conditions and anatomies from precise excision in delicate areas to rapid removal of large and bulky lesions.
Published
2024-07-04
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

Related Records

Product Codes

CodeName
EQJBur, Ear, Nose And Throat

Product Code Classifications

CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08904461001670PackageGS110In Commercial Distribution
08906039318272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08904461001670089044610016708904461001670
08906039318272089060393182728906039318272

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length70Millimeter
Outer Diameter2Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
930270428
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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