AccessGUDID - DEVICE: V. Mueller (70885403067794)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: 23275-740
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 23275-740
Company Name: CAREFUSION 2200, INC

Primary DI Number: 70885403067794
Issuing Agency: GS1
Commercial Distribution End Date: February 15, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller ROUND STICK SPONGE X-RAY DETECTABLE 1IN (25MM)

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":	Yes
For Single-Use:	Yes
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?
13698	Dissection sponge	A sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDY	GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: d49aef1e-79ea-4656-8b8b-e2a25f247362
Public Version Date: March 04, 2022
Public Version Number: 2
DI Record Publish Date: July 12, 2018