AccessGUDID - DEVICE: V. Mueller (10885403062421)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: OP5710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OP5710
Company Name: STERIS CORPORATION

Primary DI Number: 10885403062421
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: V. Mueller KNAPP STRABISMUS SCISSORS SLIGHTLY CURVED BLADES BLUNT/BLUNT OVERALL LENGTH 4 inches 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?
63479	Ophthalmic strabismus scissors, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut the muscles of the eye during strabismus surgery. It comprises two pivoted blades that usually have finger and thumb ring-handles, and which cut with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. It is not intended for intraocular surgery. 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: 58d83ac0-df0a-44e1-98da-7758c44347f5
Public Version Date: August 21, 2024
Public Version Number: 6
DI Record Publish Date: January 02, 2019