AccessGUDID - DEVICE: V. Mueller (10885403096907)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: OP1610
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OP1610
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403096907
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller CORBETT FOREIGN BODY SPUD TIP 2 MM WIDE BLADE SLIGHTLY CURVED ON FLAT OVERALL LENGTH 4-3/4" (12.1CM)

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?
16025	Eye spud	A hand-held, manual, ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle at the proximal end and a thin concave blade with a rounded nose at the distal end. The ophthalmologist uses this tip to remove the foreign body/object. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNA	Spud, 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: 01eda09a-2826-4e4f-8397-eba60d95c0d9
Public Version Date: September 26, 2023
Public Version Number: 2
DI Record Publish Date: September 07, 2018