FDA.report

Aligned Medical Solutions

Primary DI
B098AMS101061
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS10106
Catalog number
AMS10106
Device description
SKIN RECOVERY BIN A/B
Published
2024-09-11
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
LROGeneral Surgery Tray

Product Code Classifications

CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B098AMS101061PackageHIBCC1In Commercial Distribution
B098AMS101060PrimaryHIBCC0

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
8006377056CUSTOMERSERVICE@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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B098AMS13405D1Aligned Medical SolutionsAMS13405DAMS13405D2026-01-09
B098AMS13432C1Aligned Medical SolutionsAMS13432CAMS13432C2026-01-09
B098AMS14519B1Aligned Medical SolutionsAMS14519BAMS14519B2026-01-09
B098AMS14927C1Aligned Medical SolutionsAMS14927CAMS14927C2026-01-09
B098AMS15157D1Aligned Medical SolutionsAMS15157DAMS15157D2026-01-09
B098AMS15515D1Aligned Medical SolutionsAMS15515DAMS15515D2026-01-09
B098AMS15768A1Aligned Medical SolutionsAMS15768AAMS15768A2026-01-09
B098AMS15798A1Aligned Medical SolutionsAMS15798AAMS15798A2026-01-09
B098AMS15801B1Aligned Medical SolutionsAMS15801BAMS15801B2026-01-09
B098AMS15853A1Aligned Medical SolutionsAMS15853AAMS15853A2026-01-09
B098AMS16553B1Aligned Medical SolutionsAMS16553BAMS16553B2026-01-09
B098AMS16554B1Aligned Medical SolutionsAMS16554BAMS16554B2026-01-09
B098AMS16643B1Aligned Medical SolutionsAMS16643BAMS16643B2026-01-09

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