AccessGUDID - DEVICE: MABIS DMI (00041298003656)

GUDID

Device Identifier (DI) Information

Brand Name: MABIS DMI
Version or Model: 970-4002-0000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 970-4002-0000
Company Name: D-M-S HOLDINGS, INC.

Primary DI Number: 00041298003656
Issuing Agency: GS1
Commercial Distribution End Date: September 21, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 062028220 *Terms of Use

Device Description: OB KIT FOR NEW YORK CITY

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
60644	Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 65b54b3e-ffaf-4272-b327-b7c318cae232
Public Version Date: September 22, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 2016