FDA.report

Rumex

Primary DI
00840159905029
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
11-056S
Catalog number
11-056S
Device description
Gills-Vannas Capsulotomy Scissors, Straight, Sharp Tips, 10.00 mm Blades, Flat Handle, Length 88 mm, Stainless Steel
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

Related Records

Product Codes

CodeName
HNFScissors, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840159905029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159905029008401599050298401599050290840159905029

GMDN Terms

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
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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