AccessGUDID - DEVICE: Ophthalmic Retractor (00841668100974)

GUDID

Device Identifier (DI) Information

Brand Name: Ophthalmic Retractor
Version or Model: K1-8220
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K1-8220
Company Name: KATENA PRODUCTS, INC.

Primary DI Number: 00841668100974
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085668598 *Terms of Use

Device Description: DESMARRES LID RETRACTOR #2

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?
35314	Periocular/lacrimal retractor, hand-held, reusable	A hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. 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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 15 Millimeter
Device Size Text, specify: Size 2

Device Record Status

Public Device Record Key: c5fce9f2-1949-4b64-a70a-2a9bc63354e8
Public Version Date: December 15, 2022
Public Version Number: 2
DI Record Publish Date: September 14, 2020