AccessGUDID - DEVICE: V. Mueller (10885403097010)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: OP1810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OP1810
Company Name: STERIS CORPORATION

Primary DI Number: 10885403097010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: V. Mueller HEATH CHALAZION CURETTE 4MM CUP, 1 SHARP and 1 DULL EDGE ANGLED 30DEG OVERALL LENGTH 4-1/2 inches 11.5CM

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?
32772	Ophthalmic curette, reusable	A hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNZ	Curette, 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: c2a2951c-d6c3-4b0d-9abf-1e9485361b57
Public Version Date: August 23, 2024
Public Version Number: 4
DI Record Publish Date: April 15, 2020