AccessGUDID - DEVICE: Fischer-USA (00860010356203)

GUDID

Device Identifier (DI) Information

Brand Name: Fischer-USA
Version or Model: NCI (Box of 10)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9288
Company Name: Fischer Surgical, Inc.

Primary DI Number: 00860010356203
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 027019860 *Terms of Use

Device Description: NCI Spatula (Box of 10)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48161	Donor cornea delivery set	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OTZ	Graft Insertion Instrument For Endothelial Keratoplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110734	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b10b6a3d-3112-446c-93b0-ead290c8ced2
Public Version Date: October 23, 2023
Public Version Number: 1
DI Record Publish Date: October 13, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00860010356265 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 314-303-7753
Email: sales@fischersurgical.com

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