AccessGUDID - DEVICE: Sterile,Single Use,Kelman-Mcpherson LensForceps,Angled Shafts,Flat Handle,105mm (05404027417004)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile,Single Use,Kelman-Mcpherson LensForceps,Angled Shafts,Flat Handle,105mm
Version or Model: 551199
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hasa Optix

Primary DI Number: 05404027417004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 371290408 *Terms of Use

Device Description: No description.

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?
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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 91fa2d7a-23c5-48de-a1aa-a00945ee95cb
Public Version Date: July 30, 2024
Public Version Number: 1
DI Record Publish Date: July 22, 2024