AccessGUDID - DEVICE: umbili-CLAMP (00852568002138)

GUDID

Device Identifier (DI) Information

Brand Name: umbili-CLAMP
Version or Model: A01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CLW-1004-A01
Company Name: Divergent Medical Technologies LLc

Primary DI Number: 00852568002138
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 024385611 *Terms of Use

Device Description: Umbilical Clamp - umbili-CLAMP Tamper resistant, sterile, Tyvek pouch, White, SUD. Box of 100 clamps.

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):	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
FOD	DEVICE, OCCLUSION, UMBILICAL

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: 04726df9-6651-4166-9253-208532cf1ee3
Public Version Date: July 26, 2024
Public Version Number: 1
DI Record Publish Date: July 18, 2024