FDA.report

Rumex

Primary DI
00840159905500
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
16-0309
Catalog number
16-0309
Device description
Corneal Trephine Blades, 8.50 mm, Stainless Steel
Published
2020-06-09
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

Related Records

Product Codes

CodeName
HRHTrephine, Manual, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840159905500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159905500008401599055008401599055000840159905500

GMDN Terms

TermDefinition
LASEK alcohol well, reusableA hand-held, manual, ophthalmic surgical device designed to hold a small reservoir of alcohol solution at the surface of the cornea to soften the corneal epithelium for subsequent epithelial flap creation during laser-assisted epithelial keratomileusis (LASEK) surgery. It may additionally be designed to hold/assist placement of the dedicated trephine (cylindrical cutting blade) at the surface of the eye during flap creation. This is a reusable device.

Sterilization Methods

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

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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

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