FDA.report

Medical Action Industries

Primary DI
20809160208233
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
77976
Published
2018-09-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OGSMyringotomy procedure kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGSMyringotomy Procedure KitEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160208233PackageGS120Not in Commercial Distribution
10809160208236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916020823320809160208233
1080916020823610809160208236

GMDN Terms

TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. 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
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20809160514136Medical Action Industries837402026-02-26
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20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11
20809160512255MEDICAL ACTION INDUSTRIES846262026-02-11

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