FDA.report

Globe Scientific

Primary DI
00840095606554
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
513041
Device description
Slide Mailer, Polypropylene, for 2 Slides, Natural, 100/Box, 10 Boxes/Unit
Published
2019-11-26
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
true

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
00840095606561PackageGS110In Commercial Distribution
00840095606554PrimaryGS10
00840095611336Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095606561008400956065618400956065610840095606561
00840095606554008400956065548400956065540840095606554
00840095611336008400956113368400956113360840095611336

GMDN Terms

TermDefinition
Specimen container mailer, non-insulatedA non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities and is intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106793995
Device count
100
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840095689533Globe Scientific 154205RS2025-07-07
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00840095689557Globe Scientific 154235RS2025-07-07
00840095689595Globe Scientific 154005F2025-07-07
00840095689601Globe Scientific 154020F2025-07-07
00840095689618Globe Scientific 154035F2025-07-07
00840095689625Globe Scientific 154005FS2025-07-07
00840095689632Globe Scientific 154020FS2025-07-07
00840095689649Globe Scientific 154035FS2025-07-07
00840095689656Globe Scientific 154105FS2025-07-07

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