FDA.reportPublic FDA data

AtamA System

Primary DI
00816589021240
Brand
AtamA System
Company
MONTERIS MEDICAL INC
Model
20648
Catalog number
ASA001
Device description
Starburst Adapter
Published
2022-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOSCoil, magnetic resonance, specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816589021240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816589021240008165890212408165890212400816589021240

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter44.45Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight

Contacts#

Phone, Email table
PhoneEmail
+1(866)799-7655jhoneck@monteris.com

Regulatory Flags#

DUNS number
021415875
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816589021615Brasseler Twist Drillbit21332213322026-07-03
00816589021622Brasseler Twist Drillbit21345213452026-07-03
00816589021608Mini-Bolt Accessory Kit21180CMB000-AA2026-02-23
00816589021219Fiducial Marker, Sterile212512025-02-07
00816589021202Mini-Bolt System29008CMB016-AA-R2024-11-12
00816589021226Mini-Bolt System21247CMB-ST2024-08-08
00816589021196Mini-Bolt System21155CMBVUE-UP2024-05-20
00816589021585NeuroBlate NB3 FullFire™ 1.6 Laser Probe22002FFD-0162024-01-02
00816589021189Mini-Bolt System21228CMB-VX2024-03-21
00816589021158Mini-Bolt System21224CMB016-AA2023-12-20
00816589021561Mini-Bolt System21165CMB016-S2023-12-20
00816589021578Mini-Bolt System21209CMB016-UP2023-12-20
00816589021592Mini-Bolt System22004CMB016-MS2023-12-20
00816589021165Mini-Bolt System21237CMB022-VA2023-09-10
00816589021172Mini-Bolt System21239CMB033-VA2023-09-10
00816589021257Mini-Bolt System20755CMB0222022-12-14
00816589021264Mini-Bolt System20820208202022-12-14
00816589021271Mini-Bolt System20821208212022-12-14
00816589021288Mini-Bolt System21065210652022-12-14
00816589021295Mini-Bolt System20802208022022-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838111622Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838112667Smart Fit Knee 3.0TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838131866Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838133235dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838133242dS MSK S 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00195278925282NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2026-05-11
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
00814848020836Contour Hand Wrist 0.55TQUALITY ELECTRODYNAMICS LLCMOS2026-04-23
00850083516000Nuzzle Body Array, 1.5TInkspace Imaging, Inc.MOS2026-04-21
00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)Inkspace Imaging, Inc.MOS2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)Inkspace Imaging, Inc.MOS2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)Inkspace Imaging, Inc.MOS2026-04-21
00884838130548DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130555DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130562DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130579DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130586DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130593DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130609DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130616DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130623DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132597DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132603DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838093089MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838093096MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838093102MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098190MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098367MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098510MRI CoilsPhilips Ds North America LLCMOS2025-10-01