AccessGUDID - DEVICE: Surgical Direct (B382S342911000)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Direct
Version or Model: S34291.100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S34291.100
Company Name: Surgical Direct, Inc.

Primary DI Number: B382S342911000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124367223 *Terms of Use

Device Description: 5 1/4 Inch O Conner Scleral Depressor-Marker, 3mm Tear Drop Shape End, and 1.5mm Gass Marker End

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?
12442	Corneal marker, single-use	A manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMR	Marker, ocular

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: 5fbc4d00-d558-4352-9aad-98d75ff5b8de
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: November 23, 2022