AccessGUDID - DEVICE: AGRICOLA RETRACTOR 3 X 3 PRG. (G006D1095500)

GUDID

Device Identifier (DI) Information

Brand Name: AGRICOLA RETRACTOR 3 X 3 PRG.
Version or Model: D10-9550
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D10-9550
Company Name: DAUD JEE MFG. CO

Primary DI Number: G006D1095500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645508946 *Terms of Use

Device Description: To retract open the eyelids to keep eyes open during surgery over the eyeball

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):	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?
63431	Intraocular retractor, reusable	A dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNI	Retractor, 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 [?]
Ethylene Oxide
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: a4d99cd5-3e6a-4711-b3b1-2ab4722988e9
Public Version Date: December 21, 2022
Public Version Number: 1
DI Record Publish Date: December 13, 2022