Fischer-USA

Primary DI
00860010356203
Brand
Fischer-USA
Company
Fischer Surgical, Inc.
Model
NCI (Box of 10)
Catalog number
9288
Device description
NCI Spatula (Box of 10)
Published
2023-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTZGraft Insertion Instrument For Endothelial Keratoplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTZGraft Insertion Instrument For Endothelial KeratoplastyOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110734000NCI SPATULAFischer Surgical, Inc.2012-05-31OTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010356203PrimaryGS10
00860010356265Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010356203008600103562038600103562030860010356203
00860010356265008600103562658600103562650860010356265

GMDN Terms#

Term, Definition table
TermDefinition
Donor cornea delivery setA collection of sterile devices designed to hold and deliver prepared donor endothelial tissue for transplantation into a recipient eye following the removal of Descemet's membrane and dysfunctional endothelium from the patient's cornea during ophthalmic surgery. It typically consists of a preparation base, a cartridge which holds the tissue in a double-coil preventing the surfaces/edges from folding and touching, and an introducer to manually position the cartridge from where the tissue is glided into the eye in correct orientation to unfold. This set is only used for partial replacement of dysfunctional corneal cell layers and not for total cornea replacement. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
314-303-7753sales@fischersurgical.com

Regulatory Flags#

DUNS number
027019860
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010356241Fischer-USANevyas MICS Capsulorrhexis ForcepsFF65612023-10-12
00860010356258Fischer-USAStern Gill Scissors Extra Thin 10mmFS75052023-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855934007485EndoSerter-PLCorneaGen LLCOTZ2023-06-09
00855934007003EndoSerterCorneaGen LLCOTZ2020-11-03