FDA.reportPublic FDA data

ALGERBRUSH II CORNEAL RUST RING REMOVER

Primary DI
00192896012622
Brand
ALGERBRUSH II CORNEAL RUST RING REMOVER
Company
SONTEC INSTRUMENTS, INC.
Model
11-4601
Catalog number
11-4601
Device description
ALGERBRUSH II CORNEAL RUST RING REMOVER 1 MILLIMETER BURR BATTERY POWERED COMPLETE SET
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOGBurr, Corneal, Battery-PoweredOphthalmic1
OHWBurr, Corneal, Battery Powered, Rust Ring RemovalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896012622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896012622001928960126221928960126220192896012622

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
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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00192896123908Debakey Forceps2200-168L2200-168L2026-10-14
00192896123915Ceramitec Debakey Forceps2200-172CL2200-172CL2026-10-14
00192896123922Knurled Nut2500-200-1B2500-200-1B2026-10-14
00192896123939Bishop Harmon Tissue Forceps14-380114-38012026-10-14
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00192896097056Laparoscopic Bulldog Clamp2901-281-252901-281-252019-05-09
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00192896123793Adson Tissue Forceps140-302DLQ140-302DLQ2026-10-06
00192896123809Micro Skinner Forceps140-519M140-519M2026-10-06
00192896123816Jacobson Needle Holder2300-142D2300-142D2026-10-06
00192896123823Thumb Dressing Forceps136-610Q136-610Q2026-10-06
00192896123830Thumb Dressing Forceps136-615Q136-615Q2026-10-06
00192896123847Thumb Dressing Forceps136-619Q136-619Q2026-10-06
00192896123854Gum Scissors475-153Q475-153Q2026-10-06
00192896111394Laparoscopic Bulldog Clamp2901-281-60T2901-281-60T2021-10-22
00192896056282ALLIGATOR FORCEPS1271-0101271-0102018-09-27

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