FDA.reportPublic FDA data

Rumex

Primary DI
00840159900215
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
16-141
Catalog number
16-141
Device description
Alger Brush Rust Ring Remover With 0.50 mm Burr, Length 105 mm
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
HIYBrush, Haidinger, (Including Macular Integrity)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIYBrush, Haidinger, (Including Macular Integrity)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159900215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159900215008401599002158401599002150840159900215

GMDN Terms#

Term, Definition table
TermDefinition
Eye brushA brush intended to be used to gather tissue samples or to apply materials to the surface of the eye and/or its associated structures. This instrument typically consists of a handle at one end and bristles, fibres or spines, at the other. The bristles, fibres or spines may be mounted along a single plane or radiate out around a central shaft. The shaft-like handle may be flexible or rigid and the bristles may be soft or stiff. 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
B945BC10420BernellBernellHIY2026-05-02
B945BC10440BernellBernellHIY2026-05-02
B945BC675C0BernellBernellHIY2026-05-02
B945BC675INC0BernellBernellHIY2026-05-02
B945MIT20BernellBernellHIY2026-05-02
B945MIT2U0BernellBernellHIY2026-05-02
B945BC10350BernellBernellHIY2026-04-30
B945BC10410BernellBernellHIY2026-04-30
00840159900208RumexRUMEX INTERNATIONAL CORP.HIY2020-06-09