FDA.reportPublic FDA data

Invivo KITS (Disposables)

Primary DI
00884838073012
Brand
Invivo KITS (Disposables)
Company
Philips Ds North America LLC
Model
Grid Immobilization Plate BBC
Catalog number
989603203523
Device description
Grid Immobilization Plate BBC
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032576000BIOPSY BREAST COIL, MODEL BBCMri Devices Corp.2003-10-23MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838073012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838073012008848380730128848380730120884838073012

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)468-4861dynasupport@invivocorp.com

Regulatory Flags#

DUNS number
009237140
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838100114Invivo4535-302-233312020-04-17
00884838066991Invivo7840112016-09-23
00884838072558Invivo989603205282016-09-23
00884838072565Invivo989603203012016-09-23
00884838072572Invivo989603203022016-09-23
00884838073456Invivo989603208782016-09-23
00884838073463Invivo989603208792016-09-23
00884838081543Invivo7840122016-09-23
00884838082885Invivo989603210042017-07-28
00884838083592Invivo7840012016-09-23
00884838098459PhilipsdS FLEX-S 1.5T4598017299712021-06-11
00884838080997GE16ch Shoulder Coil4598008700112016-09-23
00884838081734InvivoBiopsy Grid (User-sterilized)4598015086412016-09-23
00884838107977MRI CoilsdS Microscopy 23mm, Ingenia 1.5T4598017950422021-10-28
00884838065390InvivoSENSE MSK M 8ch 1.5T4535303103522016-09-23
00884838072923KITS (Disposables)Needle Block, 8G9896032034532016-09-23
00884838072930KITS (Disposables)Needle Block, 12G9896032034632016-09-23
00884838072961KITS (Disposables)Needle Block, 18G9896032034832016-09-23
00884838072992KITS (Disposables)MRI Needle Sleeve 16G9896032043132016-09-23
00884838073067Invivo KITS (Disposables)Pillar Immobilization Plate BBC9896032035832016-09-23

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