AccessGUDID - DEVICE: Tyrode's Solution - Acidified (00893727002996)

GUDID

Device Identifier (DI) Information

Brand Name: Tyrode's Solution - Acidified
Version or Model: 99252-12X5ML
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 99252
Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.

Primary DI Number: 00893727002996
Issuing Agency: GS1
Commercial Distribution End Date: August 06, 2020
Device Count: 12
Labeler D-U-N-S® Number*: 057475246 *Terms of Use

Device Description: Tyrode's Solution - Acidified

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):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46553	Assisted reproduction microtool	A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQL	Media, Reproductive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991339	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: 3e540c11-6332-4d45-8379-a0bfdf63186d
Public Version Date: August 06, 2020
Public Version Number: 6
DI Record Publish Date: September 10, 2016