AccessGUDID - DEVICE: Seraplas (04038917081481)

GUDID

Device Identifier (DI) Information

Brand Name: Seraplas
Version or Model: 53.419
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 53.419
Company Name: Sarstedt Aktiengesellschaft & Co.KG

Primary DI Number: 04038917081481
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 388000270 *Terms of Use

Device Description: Seraplas V13

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?
63765	Assay container liner IVD	A device intended to be used to create a barrier between the assay container and devices used for aspirating and/or depositing (e.g., pipette), to prevent reagent carryover and spillage, during in vitro diagnostic procedures. It may be used to perforate a sealed single or multichannel assay container and create a working channel for subsequent liquid handling. It is typically made of synthetic polymer materials (e.g., plastic) as a single component, or a strip of multiple liners. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 475223e3-7199-48af-8387-981c1d9c1040
Public Version Date: January 15, 2025
Public Version Number: 5
DI Record Publish Date: September 17, 2019