FDA.report

Eckardt Pressure Plate.(23 gauge / 0.6 mm)

Primary DI
08717872008257
Brand
Eckardt Pressure Plate.(23 gauge / 0.6 mm)
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
2115
Catalog number
2115
Published
2021-01-29
Public version status
New
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
HNXDepressor, Orbital

Product Code Classifications

CodeDeviceSpecialtyClass
HNXDepressor, OrbitalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717872008257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717872008257087178720082578717872008257

GMDN Terms

TermDefinition
Orbital depressor, reusableA hand-held ophthalmic surgical instrument designed for extra-orbital displacement of the sclera to facilitate examination of the surrounding area in the orbital cavity during eye surgery; it does not provide illumination. Sometimes referred to as a scleral depressor it is typically a double-ended device, that can be of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working ends slightly angled to improve organ/tissue manipulation. It is usually made of high-grade stainless steel. This is a reusable device.

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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