AccessGUDID - DEVICE: V. Mueller (10885403130199)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: SU15410
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SU15410
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403130199
Issuing Agency: GS1
Commercial Distribution End Date: February 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: SAALFELD COMEDO EXTRACTOR DOUBLE-ENDED, WITH LANCET OVERALL LENGTH 4-1/2" (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?
57817	Comedo expressor	A manual instrument designed for pressing or squeezing out a comedo (black head) from the mouth of sebaceous follicles. It typically consists of a hand-held device with one or both ends appropriately configured (e.g., crimped, spoon-like, forming loops) for the extraction of plugging comedos. The instrument is used in the treatment of acne; it may be used also for plantar warts. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZS	CURETTE, SURGICAL, GENERAL USE

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: 461261ff-d5cc-49be-995f-fea358360c74
Public Version Date: December 11, 2019
Public Version Number: 3
DI Record Publish Date: September 17, 2018