FDA.report

Aligned Medical Solutions

Primary DI
B098AMS135101
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS13510
Catalog number
AMS13510
Device description
LAPAROTOMY PACK
Published
2023-07-11
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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B098AMS135101PackageHIBCC5In Commercial Distribution
B098AMS135100PrimaryHIBCC0

GMDN Terms

TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18006377056CUSTOMESERVICE@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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B098AMS12913A1Aligned Medical SolutionsAMS12913AAMS12913A2026-01-09
B098AMS13295C1Aligned Medical SolutionsAMS13295CAMS13295C2026-01-09
B098AMS13321E1Aligned Medical SolutionsAMS13321EAMS13321E2026-01-09
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