AccessGUDID - DEVICE: Ahmed Tube Inserter (00892064002331)

GUDID

Device Identifier (DI) Information

Brand Name: Ahmed Tube Inserter
Version or Model: TI
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TI
Company Name: NEW WORLD MEDICAL, INCORPORATED

Primary DI Number: 00892064002331
Issuing Agency: GS1
Commercial Distribution End Date: September 24, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 622768711 *Terms of Use

Device Description: Tube Inserter

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
63413	Ophthalmic implant handling forceps, reusable	A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNR	Forceps, 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
No Device Sizes

Device Record Status

Public Device Record Key: e17835d8-ed05-4ba2-afb3-cbf42e84cd82
Public Version Date: October 05, 2022
Public Version Number: 2
DI Record Publish Date: October 11, 2018