FDA.report

Microscope Slide Mailer

Primary DI
10810050854396
Brand
Microscope Slide Mailer
Company
TYPENEX MEDICAL LLC
Model
SM0202
Device description
CARDBOARD SLIDE MAILER W/DIVIDERS & LID, FOR 2PCSOF 25.0X75.0MM (1"X3") SLIDES
Published
2022-02-17
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
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810050854396PackageGS150In Commercial Distribution
00810050854399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085439610810050854396
00810050854399008100508543998100508543990810050854399

GMDN Terms

TermDefinition
Microscope slide folderA device designed to safely store stained microscope slides so that they are protected; particularly during transport/presentation of the slides. This device is available as flat folder in which the slides are placed flat into recesses and covered with a transparent or folding flap that will protect them. It may be colour-coded to help organize the slides and have a facility for labelling each slide (e.g., a bar-coded label). Some types are ready punched with holes suitable for storage in a ring binder. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
600850213
Device count
1
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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