AccessGUDID - DEVICE: Dimension® Pipette Tips (00842768014031)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Pipette Tips
Version or Model: 10445570
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STM1
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768014031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5000
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Dimension® Sample Transfer Module Pipette Tips

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:	No
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?
63337	Pipette tip IVD	A device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette, or a dispenser, and where the required volume of liquid (e.g., reagent, buffer, biological specimen) is drawn for delivery to a target receptacle during an in vitro diagnostic procedure. It is typically used for manual procedures or onboard automated liquid handling instruments or analysers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 951581b3-020c-4e15-a7d1-ca09e36d47da
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2018