FDA.report

Aligned Medical Solutions

Primary DI
B098AMS140581
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS14058
Catalog number
AMS14058
Device description
EAR PACK
Published
2023-06-15
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
OGREar, Nose, And Throat Surgical Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B098AMS140581PackageHIBCC3In Commercial Distribution
B098AMS140580PrimaryHIBCC0

GMDN Terms

TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-637-7056CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM

Regulatory Flags

DUNS number
106580145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
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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B098AMS16553B1Aligned Medical SolutionsAMS16553BAMS16553B2026-01-09
B098AMS16554B1Aligned Medical SolutionsAMS16554BAMS16554B2026-01-09
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