FDA.report

REMEL

Primary DI
00848838023484
Brand
REMEL
Company
REMEL, INC.
Model
R21259
Catalog number
R21259
Device description
PVA-Modified Fixative 500ml Each
Published
2023-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LDXFixative, Metallic Containing

Product Code Classifications

CodeDeviceSpecialtyClass
LDXFixative, Metallic ContainingPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848838023484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838023484008488380234848488380234840848838023484

GMDN Terms

TermDefinition
Faecal specimen container IVD, fixativeA covered plastic receptacle containing a fixative solution [e.g., sodium acetate, acetic acid and/or formaldehyde (SAF), Schaudinn’s, polyvinyl alcohol (PVA) or acid alcohol] intended to be used for the collection, and preservation and/or transport, of a faecal specimen for analysis and/or other investigation [e.g., evaluation for the presence of intestinal parasites and/or their eggs (ova)]. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
065769564
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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