FDA.reportPublic FDA data

ALGERBRUSH DIAMOND BURR

Primary DI
00192896012677
Brand
ALGERBRUSH DIAMOND BURR
Company
SONTEC INSTRUMENTS, INC.
Model
11-4614
Catalog number
11-4614
Device description
ALGERBRUSH DIAMOND BURR ROUND MEDIUM GRIT WITH CHUCK
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHWBurr, Corneal, Battery Powered, Rust Ring Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHWBurr, Corneal, Battery Powered, Rust Ring RemovalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896012677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896012677001928960126771928960126770192896012677

GMDN Terms#

Term, Definition table
TermDefinition
Corneal bur, rust ring removal, reusableA small shaft made of a hard metal (e.g., steel) with fluting or cutting planes designed for gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object. It is attached to the tip of a special slow-rotation powered ophthalmic handpiece. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896123427Trocar20910-1120910-112026-06-02
00192896123434Flexible Trocar Sleeve15-16141-0315-16141-032026-06-02
00192896123441Barraquer Anis Needle Holder15-3810Q15-3810Q2026-06-02
00192896105553Rochester Carmalt Forceps1100-1541100-1542020-11-16
00192896105591Bone Tamp335-400335-4002020-11-18
00192896105607Bone Tamp335-404335-4042020-11-18
00192896102637Carmalt Forceps1100-152L1100-152L2020-06-15
00192896101524BONE TAMP1103-197A1103-197A2020-05-11
00192896099715WILDE ETHMOID RONGEUR468-622468-6222018-09-20
00192896094109ROCHESTER CARMALT FORCEPS1100-153Q1100-153Q2019-03-07
00192896094475ROCHESTER CARMALT FORCEPS1100-152Q1100-152Q2019-03-07
00192896094567ROCHESTER CARMALT FORCEPS1100-150Q1100-150Q2019-03-07
00192896094758BLAKESLEY ETHMOID RONGEUR468-686468-6862019-03-07
00192896095861ETHMOID PEDIATRIC RONGEUR468-590Q468-590Q2019-03-25
00192896041028ETHMOID PEDIATRIC RONGEUR468-580468-5802018-09-10
00192896041035ETHMOID PEDIATRIC RONGEUR468-585468-5852018-09-11
00192896041042ETHMOID PEDIATRIC RONGEUR468-590468-5902018-09-10
00192896041059WILDE ETHMOID RONGEUR468-600468-6002018-09-10
00192896041066WILDE ETHMOID RONGEUR468-606468-6062018-09-11
00192896041073WILDE ETHMOID RONGEUR468-610468-6102018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613005184MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005191MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005207MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005221MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005245MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005252MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005276MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005283MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005290MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005306MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005313MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005320MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613020002MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613021122MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613036492MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613036508MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613102432MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613122089MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613122478MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005214MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00194613005238MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00194613005269MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00194613020019MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00194613021115MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00194613109189MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00841668132623ALGERBRUSH CORN RUST RING REM 0.5MM BURRKATENA PRODUCTS, INC.OHW2022-12-07
00841668132630ALGERBRUSH RUST RING REM BURR 0.5MMKATENA PRODUCTS, INC.OHW2022-12-07
00841668132647ALGERBRUSH CORN RUST RING REM BURR 1.0MMKATENA PRODUCTS, INC.OHW2022-12-07
00841668132654YOSHIDA DIAMOND COATED BURRKATENA PRODUCTS, INC.OHW2022-12-07
00841668132661ALGERBRUSH RUST RING REM CHUCK .5MM BURRKATENA PRODUCTS, INC.OHW2022-12-07