AccessGUDID - DEVICE: EYE SPECULA (B974ES500P0)

GUDID

Device Identifier (DI) Information

Brand Name: EYE SPECULA
Version or Model: EYE SPECULA HOLLOW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ES500P
Company Name: DR.FRIGZ INTERNATIONAL(PVT)LTD,

Primary DI Number: B974ES500P0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645680125 *Terms of Use

Device Description: EYE SPECULA HOLLOW 15MM 1-1/2 INCH LENTH

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):	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?
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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 1.5 Inch

Device Record Status

Public Device Record Key: 80e9ace7-b2c2-434b-93ca-90bda7955c36
Public Version Date: November 29, 2022
Public Version Number: 1
DI Record Publish Date: November 21, 2022