FDA.report

TRANSPORT STORAGE CONTAINER

Primary DI
08435389816720
Brand
TRANSPORT STORAGE CONTAINER
Company
BIOTECHNOLOGY INSTITUTE SL
Model
TSC
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08435389816720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08435389816720084353898167208435389816720

GMDN Terms

TermDefinition
General specimen receptacle transport containerA non-sterile, portable device designed for the transportation of one or multiple clinical specimen receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of sizes, shapes, and materials. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
461665312
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
true
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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08435389828952EXTRACTOR FOR IMPLANTS 8EXIM82026-01-30
08435389828969EXTRACTOR FOR IMPLANTS 9EXIM92026-01-30
08435389829027SHORT DRILL; Ø2,2 MMF22CS2026-01-30
08435389829034SHORT DRILL; Ø2,3 MMF23CS2026-01-30
08435389829041SHORT DRILL; Ø2,4 MMF24CS2026-01-30
08435389829058SHORT DRILL; Ø2,0 MMF20CS2026-01-30
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08435389830061EXTRA SHORT INITIAL DRILLFIXS2026-01-30
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08435389830085EXTRA SHORT DRILL; Ø1,8/2,5 MMF1825XS2026-01-30
08435389830092EXTRA SHORT DRILL; Ø2,5 MMF25XS2026-01-30
08435389830108EXTRA SHORT DRILL; Ø2,8 MMF28XS2026-01-30
08435389830115EXTRA SHORT DRILL; Ø3 MMF30XS2026-01-30
08435389830269HEATING OVEN H-PLUSBTI H-PLUS2026-01-30
08435389830276DRILL HOLDER FOR EXTRA SHORT DRILLSFFXS2026-01-30
08435389830320SHORT DRILL; Ø1.5 MMF15CS2026-01-30
08435389829706EXPANDED SQUARE INTERFACE; MULTI-IM ABUTMENT; WIDE PLATFORMISMIPAX2026-01-29
08435389829713EXPANDED SQUARE INTERFACE; UNIT ABUTMENT; WIDE PLATFORMISMIUPAX2026-01-29
08435389829843MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; Ø3,5; H 4,5MMINTMIP335452026-01-29
08435389829850MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; H 4,5MMINTMIP3452026-01-29

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