AccessGUDID - DEVICE: GM501 Gradient 45% (00858604006139)

GUDID

Device Identifier (DI) Information

Brand Name: GM501 Gradient 45%
Version or Model: 4GM501GR-45-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAMILTON THORNE, INC.

Primary DI Number: 00858604006139
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 152161337 *Terms of Use

Device Description: GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41427	Cell centrifugation/density gradient separation reagent IVD	A substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQL	Media, Reproductive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053494	000

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 59fe647b-4c0f-4fab-9c46-6fad2cc4fa95
Public Version Date: May 10, 2021
Public Version Number: 1
DI Record Publish Date: April 30, 2021