AccessGUDID - DEVICE: Stephens Instruments (00810061910411)

GUDID

Device Identifier (DI) Information

Brand Name: Stephens Instruments
Version or Model: ST5-1804
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST5-1804
Company Name: KRISHNA IMPORTS INC

Primary DI Number: 00810061910411
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081853285 *Terms of Use

Device Description: Titanium Humer Lens Folding Forceps

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?
47871	Intraocular lens folder	A hand-held, sterile, device designed to uniformly fold a foldable intraocular lens (IOL) in order to reduce its natural physical size so that the IOL can be removed from the IOL folder with an implantation forceps and be implanted into the anterior or posterior chamber of the eye through a small incision during ophthalmic surgery. It is typically made of synthetic material (e.g., polypropylene) and is designed to accept the IOL in its natural unfolded state, when in place the operator activates the folding mechanism. This is a single-use device.	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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c79160b-cc92-461b-a11d-6def6613c782
Public Version Date: September 30, 2020
Public Version Number: 1
DI Record Publish Date: September 22, 2020