AccessGUDID - DEVICE: V. Mueller (10885403094545)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: OP0918-007
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OP0918-007
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403094545
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: TREPHINE BLADE, DISPOSABLE, SHORT, 7.75MM

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?
46251	Corneal trephine, single-use	A sterile, ophthalmic surgical blade designed to cut and remove circular sections of the cornea (corneal buttons) and/or sclera from a patient to prepare for graft implantation, or from cadaveric donors to obtain grafts. It is typically a sharp, beveled, hollow cylinder, of different diameters, having a circular, saw-like working edge. It is an exchangeable device that may be attached to a manually rotated handle or to a powered rotary surgical handpiece. This is a single-use device typically made of high-grade stainless steel.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRH	Trephine, manual, 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: ec9f3f5c-d865-4ad0-985c-1121b65253c7
Public Version Date: April 08, 2019
Public Version Number: 2
DI Record Publish Date: September 05, 2018