FDA.report

Aligned Medical Solutions

Primary DI
B098CPA264041
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
CPA26404
Catalog number
CPA26404
Device description
Dental Pack Dr Foster
Published
2018-11-14
Public version status
Update
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
OFXGeneral purpose dental tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFXGeneral Purpose Dental TrayDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B098CPA264041PackageHIBCC8In Commercial Distribution
B098CPA264040PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, single-useA collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+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
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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