AccessGUDID - DEVICE: V. Mueller (10885403097072)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: OP1920
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OP1920
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403097072
Issuing Agency: GS1
Commercial Distribution End Date: January 23, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: ARLT LENS LOOP SLIGHTLY CURVED SERRATED LOOP, LOOP 14 X 4MM WIDE OVERALL LENGTH 5-3/8" (13.7CM)

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?
12319	Lens loop, reusable	A hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNB	Spoon, 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: c16e3ca6-ae39-4284-8cf7-7f2ac5007c86
Public Version Date: December 11, 2019
Public Version Number: 3
DI Record Publish Date: September 07, 2018