FDA.reportPublic FDA data

Rumex

Primary DI
00840159905524
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
16-052-5.0B
Catalog number
16-052-5.0B
Device description
Disk Shaped Diamond Dusted Burr 5.00 mm Diameter, Burr Only
Published
2020-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOFBurr, Corneal, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOFBurr, Corneal, ManualOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159905524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159905524008401599055248401599055240840159905524

GMDN Terms#

Term, Definition table
TermDefinition
Corneal bur manual instrumentA hand-held, ophthalmic surgical instrument that consists of a shaft with fluting or cutting planes of steel, or other hard metal, of various shapes at its distal end, used to excavate corneal tissue (e.g., removal of rust rings) through manual rotation. This is a one-piece instrument with no exchangeable components. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
041546137
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840159900345Rumex18-30418-3042020-06-09
00840159900406Rumex18-30518-3052020-06-09
00840159900802Rumex18-30318-3032020-06-09
00840159903384Rumex18-30118-3012020-06-09
00840159903391Rumex18-301-118-301-12020-06-09
00840159903407Rumex18-30218-3022020-06-09
00840159903414Rumex18-30718-3072020-06-09
00840159903421Rumex18-30818-3082020-06-09
00840159903438Rumex18-31818-3182020-06-09
00840159905609Rumex18-30018-3002020-06-09
00840159907900Rumex18-300-118-300-12020-06-09
00840159907917Rumex18-303-118-303-12020-06-09
00840159907924Rumex18-305-118-305-12020-06-09
00840159907931Rumex18-31018-3102020-06-09
00840159907948Rumex18-31118-3112020-06-09
00840159907955Rumex18-31218-3122020-06-09
00840159907962Rumex18-31318-3132020-06-09
00840159907979Rumex18-31418-3142020-06-09
00840159902189Rumex9-011S9-011S2020-06-04
00840159902196Rumex9-012S9-012S2020-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770460052Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
00757770460069Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
00757770460076Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
00757770460083Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
00757770535699Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
00757770460045Bausch + LombBausch & Lomb IncorporatedHOF2024-08-26
00810799031419Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031426Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031433Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031440Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031457Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031464Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031471Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031488Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00841668101247SpudKATENA PRODUCTS, INC.HOF2020-09-14
00840159903193RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159903209RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159903216RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159903223RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159903346RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159903353RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159907818RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09