AccessGUDID - DEVICE: Eckardt Membrane Pic, angled at 120 degrees. (27 gauge / 0.4 mm) (08717872017150)

GUDID

Device Identifier (DI) Information

Brand Name: Eckardt Membrane Pic, angled at 120 degrees. (27 gauge / 0.4 mm)
Version or Model: 1292.E04
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1292.E04
Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Primary DI Number: 08717872017150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
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:	No
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?
63483	Epiretinal/inner limiting membrane scraper, reusable	A hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses. It includes a dedicated textured tip (e.g., diamond-dusted polymer), intended to effectively grip/lift the membrane to allow for further manipulation (e.g., with forceps). This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HND	Spatula, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: fb8a7d8c-41e5-4565-9afd-5e07a6ba2b4a
Public Version Date: February 22, 2021
Public Version Number: 2
DI Record Publish Date: February 11, 2021