AccessGUDID - DEVICE: V. Mueller (10885403099670)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: OP5675
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OP5675
Company Name: STERIS CORPORATION

Primary DI Number: 10885403099670
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: V. Mueller MCPHERSON MICRO TENOTOMY and CONJUNCTIVAL SCISSORS, CURVED BLUNT TIPS, BLD 9MM MID-SCREW OVERALL LENGTH 3-1/4 inches 8.3CM

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?
63553	Conjunctival scissors, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut the conjunctiva and Tenon’s capsule on the eye surface to access the sclera. It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (thumb ring-handles or tweezers-like handles). It is typically made of metal and is available in various designs and sizes. It may additionally be used for cutting sutures and/or drapes, however, it is neither intended for intraocular surgery nor for other extraocular surgeries. 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: ff1252bf-e5d7-49c8-9330-664f8cff0862
Public Version Date: August 23, 2024
Public Version Number: 6
DI Record Publish Date: January 02, 2019