FDA.reportPublic FDA data

Rumex

Primary DI
00840159902707
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
13-1491
Catalog number
13-1491
Device description
John DSAEK Descemet's Stripper, "T" Shape 1.50 mm Wide x 0.60 mm High Tip, Round Handle, Length 120 mm, Round Titanium Handle
Published
2020-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HNDSpatula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159902707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159902707008401599027078401599027070840159902707

GMDN Terms#

Term, Definition table
TermDefinition
Epiretinal/inner limiting membrane scraper, reusableA hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses. It includes a dedicated textured tip (e.g., diamond-dusted polymer), intended to effectively grip/lift the membrane to allow for further manipulation (e.g., with forceps). 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

Regulatory Flags#

DUNS number
041546137
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00840159901397Rumex4-072T4-072T2020-07-27
00840159901403Rumex4-0741S4-0741S2020-07-27
00840159901410Rumex4-0741T4-0741T2020-07-27
00840159901427Rumex4-090T4-090T2020-07-27
00840159901434Rumex4-091S4-091S2020-07-27
00840159901441Rumex4-092T4-092T2020-07-27
00840159901458Rumex4-111T4-111T2020-07-27
00840159901465Rumex4-113T4-113T2020-07-27
00840159901472Rumex4-121S4-121S2020-07-27
00840159901489Rumex4-122S4-122S2020-07-27
00840159901496Rumex4-123S4-123S2020-07-27
00840159901502Rumex4-136S4-136S2020-07-27
00840159901519Rumex4-140T4-140T2020-07-27
00840159901526Rumex4-171S4-171S2020-07-27
00840159901533Rumex4-175T4-175T2020-07-27
00840159901540Rumex4-176T4-176T2020-07-27
00840159901557Rumex4-177S4-177S2020-07-27
00840159901564Rumex4-185S4-185S2020-07-27
00840159901571Rumex4-185T4-185T2020-07-27
00840159901588Rumex4-1906T4-1906T2020-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G346EP19A0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-03-24
B382S344901020Surgical DirectSurgical Direct, Inc.HND2026-03-09
G34EP223R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-02-27
G3446EP219SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-02-16
00757770636631Bausch + LombBausch & Lomb IncorporatedHND2026-02-04
05056785303367Double Ended Y and ICL Shaped ManipulatorBLINK MEDICAL LIMITEDHND2026-02-04
B382S344901080Surgical DirectSurgical Direct, Inc.HND2026-02-04
B382S344932020Surgical DirectSurgical Direct, Inc.HND2026-02-04
B382S344961000Surgical DirectSurgical Direct, Inc.HND2026-02-04
05056785303343Connor WandBLINK MEDICAL LIMITEDHND2026-01-26
00840319758540Hayden MedicalHayden Medical, Inc.HND2025-12-31
00840319758403Hayden MedicalHayden Medical, Inc.HND2025-12-24
00840319758410Hayden MedicalHayden Medical, Inc.HND2025-12-24
00852194002144HAI SpatulaHightech American Industrial Labs IncHND2025-12-16
G223M1129350Femtosecond SpatulaMedetz Surgical Instruments LLCHND2025-12-16
00757770676361Bausch + LombBausch & Lomb IncorporatedHND2025-12-12
B382S34543110T0Surgical DirectSurgical Direct, Inc.HND2025-12-10
B382S9344951010Surgical DirectSurgical Direct, Inc.HND2025-12-10
00757770695522Bausch + LombBausch & Lomb IncorporatedHND2025-11-16
00757770697892Bausch + LombBausch & Lomb IncorporatedHND2025-11-16
00757770688524Bausch + LombBausch & Lomb IncorporatedHND2025-11-14
B382S340861160Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382S344101420Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382S4088010Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382SD9340311000Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382SD9343771110Surgical DirectSurgical Direct, Inc.HND2025-11-11
G346EP55L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-26
G346EP1650Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-23
B382S9340861010Surgical DirectSurgical Direct, Inc.HND2025-09-22
G346EC222SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-18