FDA.report

Diamatrix

Primary DI
00813059014689
Brand
Diamatrix
Company
Diamatrix
Model
F630S-V
Catalog number
F630S-V
Device description
Lehner-Utrata Capsulorhexis Forceps, Angled/Vaulted 12mm Bend, Thin Triangular Tips, Flat Handle, Stainless Steel
Published
2020-07-02
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
HNQHook, Ophthalmic
HNRForceps, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813059014689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059014689008130590146898130590146890813059014689

GMDN Terms

TermDefinition
Ocular hook/spatula/manipulator, reusableA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
809555139
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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