FDA.report

Disposable Microforceps: Eckardt End-gripping.(27 gauge / 0.4 mm)

Primary DI
18717872006229
Brand
Disposable Microforceps: Eckardt End-gripping.(27 gauge / 0.4 mm)
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
1286.WD04
Catalog number
1286.WD04
Published
2021-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HNRForceps, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717872006222PrimaryGS10
18717872006229Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717872006222087178720062228717872006222
1871787200622918717872006229

GMDN Terms

TermDefinition
Ophthalmic soft-tissue manipulation forceps, probe-like, single-useA sterile, hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
407522184
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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