FDA.reportPublic FDA data

Microscope Slide Mailer

Primary DI
10810050854372
Brand
Microscope Slide Mailer
Company
TYPENEX MEDICAL LLC
Model
SM0102
Device description
SLIDES MAILER FOR 2 PCS OF 25.0X75.0MM (1"X3") SLIDES, HORIZONTAL TYPE, PP MATERIAL. NEUTRAL COLOR
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

Product Codes#

Code, Name table
CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810050854372PackageGS1100In Commercial Distribution
00810050854375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085437210810050854372
00810050854375008100508543758100508543750810050854375

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide boxA small, portable box intended to be used to safely store a number of stained microscope slides for their organization and protection during storage and transportation. It will typically have the capacity to store, e.g., 12 to 100 slides, and is available in a variety of box designs, e.g., it may have a hinged or a loose lid which may be transparent. The slides are stored upright lying on one side. Some types may facilitate stacking, one upon another, with interlocking recesses to keep them together. This device can be made of plastic, wood, and metal materials and will typically include labels to show content.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810050855850Microscope SlidesPS0404G2026-05-14
10810050855867Microscope SlidesPS0404L2026-05-14
10810050855874Microscope SlidesPS0404N2026-05-14
10810050855881Microscope SlidesPS0404P2026-05-14
10810050855898Microscope SlidesPS0404Y2026-05-14
10810050855904Embedding CassetteEC0616YXT-LASER2026-05-14
10810050855911Embedding CassetteEC0616PXT-LASER2026-05-14
10810050855928Embedding CassetteEC0616WXT-LASER2026-05-14
10810050855935Embedding CassetteEC0616EXT-LASER2026-05-14
10810050855843Rad ControlRT0301XBA2026-05-06
10810050855836Microscope SlidesLC0105B2026-03-23
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000020Sterile LabelsSL-1000022026-03-17
B050SL1000021Sterile LabelsSL-1000022026-03-17
00810050851923Specimen Collection SwabSW0202SW02022020-06-01
00810050851909Specimen Collection SwabSW0102SW01022020-06-01
00810050852388Anterior Nasal SwabSW0302SW03022020-08-20
00810050855815ThermoFlo®60612026-01-26
00810050855808Typenex Introducer SetMS2335S2025-11-17
10810050855805Typenex Introducer SetMS2335S2025-11-17

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