FDA.reportPublic FDA data

Aquamantys

Primary DI
00850043377023
Brand
Aquamantys
Company
GREEN OR LLC
Model
GR-23-313-1
Device description
Aquamantys 9.5 XL Bipolar Sealer (Reprocessed Device)
Published
2024-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211203000Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC2022-04-07NUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043377023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043377023008500433770238500433770230850043377023

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reprocessedA sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a previously used single-use device that has been processed for an additional single-use patient application.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
123227484
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850043377009AquamantysGR-23-112-12024-05-16
00850043377016AquamantysGR-23-113-12024-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044399000NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399017NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399031NES Reprocessed RF Stylet (RFS)NORTH EAST SCIENTIFIC INCNUJ2025-05-21
10888277408746MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
20888277408743MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
10888277408739MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
20888277408736MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
10888277325227MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277391987MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277414907MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680326MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680333MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680340MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680357MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680371MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680395MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680432MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719330MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719354MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719378MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719392MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
B504AEAR98310ArthrexProvisionNUJ2024-09-17
B504CB1381050ConMedProvisionNUJ2024-07-01
B504CBEN60000StrykerProvisionNUJ2024-05-22
B504CBEN70000StrykerProvisionNUJ2024-05-22
00850043377009AquamantysGREEN OR LLCNUJ2024-05-16
00850043377016AquamantysGREEN OR LLCNUJ2024-05-16
00850043377085AquamantysSTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2024-05-16
00850043377092AquamantysSTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2024-05-16