AccessGUDID - DEVICE: V. Mueller (10885403099489)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: OP5597
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OP5597
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403099489
Issuing Agency: GS1
Commercial Distribution End Date: April 22, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller IRIDOCAPSULOTOMY SCISSORS BLADES 8MM FROM MID-SCREW OVERALL LENGTH 4" (10.2CM)

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?
63481	Intraocular lens removal scissors, conventional-hinge, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut an intraocular lens (IOL) during IOL removal. It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic with tweezers-like handles, and is available with various blade designs and sizes; some designs may additionally be used for cutting sutures and drapes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNF	SCISSORS, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ff7ce377-c108-4167-bfa0-804da4215ab7
Public Version Date: October 18, 2023
Public Version Number: 4
DI Record Publish Date: January 02, 2019