FDA.report

25ga DEX™ Stiff Super Grip Forceps

Primary DI
10840096205166
Brand
25ga DEX™ Stiff Super Grip Forceps
Company
KATALYST SURGICAL LLC
Model
DVF4034-25-S
Published
2019-07-26
Public version status
Update
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
10840096205166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084009620516610840096205166

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 jaw-like grasping blades that protrude from the distal end of the shaft. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007883297
Device count
1
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
true
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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