AccessGUDID - DEVICE: Ophthlamic Speculum (10841668112424)

GUDID

Device Identifier (DI) Information

Brand Name: Ophthlamic Speculum
Version or Model: K20-1010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K20-1010
Company Name: KATENA PRODUCTS, INC.

Primary DI Number: 10841668112424
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 085668598 *Terms of Use

Device Description: DISPOSABLE BARRAQUER SPECULUM 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:	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?
46959	Eyelid speculum, single-use	A self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNC	Specula, 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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation 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: a8aa2655-6d9d-44bc-b402-6a14830ca2c7
Public Version Date: December 15, 2022
Public Version Number: 2
DI Record Publish Date: September 14, 2020