FDA.reportPublic FDA data

Rumex

Primary DI
00840159906910
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
12-211-23H
Catalog number
12-211-23H
Device description
Straight Vitreoretinal Scissors, Attached To A Universal Handle, with a Flushing System, 23 Ga
Published
2020-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159906910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159906910008401599069108401599069100840159906910

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, probe-like, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue (e.g., during anterior chamber surgery, vitrectomy). As a complete instrument it comprises two shearing blades at the end of a probe-/cannula-like shaft with a proximal slimline handle, typically operated by squeezing. It is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.

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
00190776397135MillenniumAvalign Technologies, Inc.HNF2026-07-16
04059453161574Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2026-06-03
04251047920554Vannas Capsulotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047921278Metzenbaum ScissorsA1 Medical GmbHHNF2026-05-29
04251047931680Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047931697Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047932021Super-Cut Stevens Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936395Vitrectomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936432Gerten Iridectomy ScissorA1 Medical GmbHHNF2026-05-29
G346EA4018GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2026-04-23
G2231349550Ophthalmic ScissorsMedetz Surgical Instruments LLCHNF2026-04-09
09348811004192INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
09348811004260INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
G346EA40SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-10-29
G346EA0823GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-09-29
07612717071643FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
07612717071704FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
07612717071735FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
08052276028358Retinal Tip 23G Microscissors CurvedAKTIVE SRLHNF2024-01-15
08052276028372Retinal Tip 25G Microscissors CurvedAKTIVE SRLHNF2024-01-15
08052276028464Retinal Tip vertical 20GAKTIVE SRLHNF2024-01-15
08052276028488Retinal Tip vertical 23GAKTIVE SRLHNF2024-01-15
08052276028501Retinal Tip vertical 25GAKTIVE SRLHNF2024-01-15
0805227602804455° Rotary microscissor 20G only Tip AKTIVE SRLHNF2024-01-11
08052276028129Retinal Tip 20G Microscissors CurvedAKTIVE SRLHNF2024-01-11
08052276028143Retinal Tip 20G Microscissors StraightAKTIVE SRLHNF2024-01-11
08052276028310Retinal Tip 23G Microscissors StraightAKTIVE SRLHNF2024-01-11
08052276028334Retinal Tip 25G Microscissors StraightAKTIVE SRLHNF2024-01-11
08175700144605Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700144612Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10