FDA.report

Aligned Medical Solutions

Primary DI
B098008786141
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
00878614
Catalog number
00878614
Device description
Port Tray - RX
Published
2018-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OKEPort introducer kit

Product Code Classifications

CodeDeviceSpecialtyClass
OKEPort Introducer KitGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B098008786141PackageHIBCC5In Commercial Distribution
B098008786140PrimaryHIBCC0

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various sterile surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)637-7056customerservice@alignedmedical
+1(888)637-7056customerservice@alignedmedicalsolutions.com

Regulatory Flags

DUNS number
106580145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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