FDA.report

Medical Action Industries

Primary DI
20809160011963
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
6624
Device description
Trayliner: Instrument 12X24 75/cs
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LRPTRAY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160011963PrimaryGS10
10809160011966Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916001196320809160011963
1080916001196610809160011966

GMDN Terms

TermDefinition
Instrument tray linerA non-sterile, durable foam sheet intended to line the inside of an instrument tray during a surgical procedure to protect delicate or sharp surgical instruments and prevent instrument movement. It is dedicated for use with an instrument tray and not intended to be used as a drape. This is a single-use device intended to be sterilized prior to use.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00store at room temperature

Sterilization Methods

Method

Regulatory Flags

DUNS number
092364462
Device count
75
DM exempt
true
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
true
Sterilization required before use
false

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20809160512521MEDICAL ACTION INDUSTRIES826092026-02-13
20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11

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