SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVER - SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVERWITH - AMSINO INTERNATIONAL, INC.

Duns Number:825673239

Device Description: SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVERWITH 3/8 INCH (0.95 CM) COLLECTION PORT, TETH SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVERWITH 3/8 INCH (0.95 CM) COLLECTION PORT, TETHERED CAP

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More Product Details

Catalog Number

433030411

Brand Name

SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVER

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Device Record Status

Public Device Record Key

0242e3c0-e698-43e1-8d52-10fd994c923c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

40704411004142

Quantity per Package

24

Contains DI Package

10704411004141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"AMSINO INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 89
2 A medical device with a moderate to high risk that requires special controls. 411
U Unclassified 1