FDA.report

Seraplas

Primary DI
04038917083317
Brand
Seraplas
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
53.677
Catalog number
53.677
Device description
Seraplas V11
Published
2019-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917083317PrimaryGS10
04038917165570Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917083317040389170833174038917083317
04038917165570040389171655704038917165570

GMDN Terms

TermDefinition
Assay container liner IVDA non-sterile 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.

Sterilization Methods

Method

Contacts

PhoneEmail
(800)257-5101customerservice.us@sarstedt.com
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags

DUNS number
388000270
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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