FDA.report

Eckardt Membrane Pic, angled at 120 degrees. (27 gauge / 0.4 mm)

Primary DI
08717872017150
Brand
Eckardt Membrane Pic, angled at 120 degrees. (27 gauge / 0.4 mm)
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
1292.E04
Catalog number
1292.E04
Published
2021-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNDSpatula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717872017150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717872017150087178720171508717872017150

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
407522184
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
true
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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