AccessGUDID - DEVICE: 25G Two Dimensional Cutter

GUDID

Device Identifier (DI) Information

Brand Name: 25G Two Dimensional Cutter – 16k CPM
Version or Model: 8278.VIT25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8278.VIT25
Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Primary DI Number: 08717872031965
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 407522184 *Terms of Use

Device Description: No description.

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):	Yes
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?
47787	Ophthalmic surgical instrument handle, pneumatic	A sterile, hand-held, pneumatically-powered device designed to hold and operate a compatible ophthalmic surgical instrument tip (e.g., scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a pneumatic feedline (tubing) that connects to a parent device with gas source; when gas is supplied to the handle, typically using a foot-switch, a mechanism is activated to operate the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190875	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: 50d44c0d-4178-4466-9435-e4a0b7ce9c17
Public Version Date: June 04, 2021
Public Version Number: 1
DI Record Publish Date: May 27, 2021