AccessGUDID - DEVICE: V. Mueller (10885403097782)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: OP2528-002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OP2528-002
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403097782
Issuing Agency: GS1
Commercial Distribution End Date: September 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller GRAETHER COLLAR BUTTON IRIS RETRACTOR 23GA ANGLED 30DEG

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?
63431	Intraocular retractor, reusable	A dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNI	Retractor, 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: b41ea6d6-83c1-4f30-9807-b336e2095e40
Public Version Date: March 07, 2022
Public Version Number: 2
DI Record Publish Date: December 27, 2018