FDA.report

Aligned Medical Solutions

Primary DI
B098AMS139751
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS13975
Catalog number
AMS13975
Device description
NERVE BLOCK TRAY - RX
Published
2023-07-17
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
OGJNerve Block Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OGJNerve Block TrayAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B098AMS139751PackageHIBCC20In Commercial Distribution
B098AMS139750PrimaryHIBCC0

GMDN Terms

TermDefinition
Peripheral anaesthesia single-administration set, non-medicatedA collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18006377056CUSTOMESERVICE@ALIGNEDMEDICALSOLUTIONS.COM
18006377056CUSTOMERSERVICE@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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