AccessGUDID - DEVICE: MABIS DMI (10767056113845)

GUDID

Device Identifier (DI) Information

Brand Name: MABIS DMI
Version or Model: D 9423V
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: D 9423V
Company Name: D-M-S HOLDINGS, INC.

Primary DI Number: 10767056113845
Issuing Agency: GS1
Commercial Distribution End Date: May 17, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 062028220 *Terms of Use

Device Description: NOVAPLUS UMBILICAL CORD CLAMP STERILE

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:	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?
43998	Umbilical cord clamp, single-use	A sterile, hand-held manual surgical instrument designed to temporarily compress the umbilical cord immediately after birth. It is used before cutting or ligating (e.g., with a clip) the cord, and is intended to enable aseptic haemostasis. It is typically made of plastic material and may incorporate features such as serrations on the contact area and/or a security lock. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFW	Clamp, Umbilical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: c241a93f-f9e7-4250-abfc-1c5afae60a48
Public Version Date: May 18, 2023
Public Version Number: 3
DI Record Publish Date: September 23, 2016