AccessGUDID - DEVICE: V. Mueller (10885403058479)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: MO442
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MO442
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403058479
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: LOGAN LIP TRACTION BOW LARGE 1-3/8" (3.5CM) SPREAD

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?
63252	Lip traction bow	An arch-shaped device intended to provide self-retaining traction of the cheeks (pull cheeks towards the midline) during surgical cleft lip repair, to stabilize and reduce the tension on the repair suture line; some forms may be designed to additionally provide protection after surgery. It may have spikes or use tape for skin attachment, is made of metal, and is available in various shapes and sizes. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAL	RETRACTOR, ENT

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: cdf286c6-c491-4d6a-a286-d14b06936da1
Public Version Date: December 11, 2019
Public Version Number: 2
DI Record Publish Date: September 05, 2018