AccessGUDID - DEVICE: Warm Plate (04589700010411)

GUDID

Device Identifier (DI) Information

Brand Name: Warm Plate
Version or Model: WP010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REPROLIFE INC.

Primary DI Number: 04589700010411
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 691176883 *Terms of Use

Device Description: An Individual package we offer contains 10 plates. The package has product label and letters "Warm Plate-10 Plate" are written on it.

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?
48007	Tissue cryostorage straw	A long, thin, tubular sterile device in the form of a straw used for the placement and storage of human biological samples such as embryos, oocytes, sperm, and human tissue in liquid nitrogen (LN2) or in the volumes of vapour phase LN2 in a liquid nitrogen container. It is made of materials to withstand storage in LN2 and is available in a variety of designs that may include a sliding plug or a permeable membrane plug to hold the sample. The sample is inserted into one end of the device and both ends are sealed, typically by using a thermal sealing device, creating an airtight seal to protect the sample from direct contact with the LN2. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUD	Labware, Assisted Reproduction, Exempt

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: b2729573-dc4a-4b00-940d-47ccca1711a9
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: July 12, 2019