AccessGUDID - DEVICE: NEW ORLEANS LENS LOOP (00192896013490)

GUDID

Device Identifier (DI) Information

Brand Name: NEW ORLEANS LENS LOOP
Version or Model: T12-4330
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T12-4330
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896013490
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: NEW ORLEANS LENS LOOP SINGLE ENDED TITANIUM

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?
12319	Lens loop, reusable	A hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HND	Spatula, 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 [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 5.25 Inch

Device Record Status

Public Device Record Key: 6851c38d-0cce-4ca1-b61c-448965373bba
Public Version Date: October 07, 2019
Public Version Number: 3
DI Record Publish Date: September 18, 2018