FDA.reportPublic FDA data

Aquamantys ™

Primary DI
00763000058685
Brand
Aquamantys ™
Company
MEDTRONIC NAVIGATION, INC.
Model
23-322-1
Device description
BIPO SEALER 23-322-1 AQM MIS FLEX MINI
Published
2018-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000058685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000058685007630000586857630000586850763000058685

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, single-useA 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 single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835233107
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000811129Medtronic97343782026-06-07
00763000404871StealthStation™97359632026-05-23
00199150006427Stealth AXiS97365512026-04-24
00199150071586Stealth AXiS97367642026-04-19
00199150071609Stealth AXiS97367662026-04-19
00763000928896Stealth AXiS97365172026-04-11
00763000928902Stealth AXiS97365182026-04-11
00763000928919Stealth AXiS97365212026-04-10
00763000928926Stealth AXiS97365332026-04-10
00763000945947Stealth AXiS97365202026-04-10
00763000945954Stealth AXiS97365192026-04-10
00763000983840Stealth AXiS97366782026-04-11
00763000983864Stealth AXiS97366792026-04-11
00763000983888Stealth AXiS97366802026-04-11
00763000984441Stealth AXiS97364812026-04-10
00763000984458Stealth AXiS97364822026-04-10
00763000984465Stealth AXiS97364832026-04-10
00763000984472Stealth AXiS97364842026-04-10
00763000984489Stealth AXiS97364852026-04-10
00763000984496Stealth AXiS97364862026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14