FDA.report

MEDICAL ACTION INDUSTRIES

Primary DI
20809160000646
Brand
MEDICAL ACTION INDUSTRIES
Company
MEDICAL ACTION INDUSTRIES INC.
Model
73464
Published
2016-08-23
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
OFTSpinal epidural anesthesia kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160000646PackageGS120Not in Commercial Distribution
10809160000649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916000064620809160000646
1080916000064910809160000649

GMDN Terms

TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods

Method

Regulatory Flags

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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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