FDA.reportPublic FDA data

NvisionVLE Marking Probe 17mm

Primary DI
00859591006065
Brand
NvisionVLE Marking Probe 17mm
Company
NINEPOINT MEDICAL, INC.
Model
95301-M-17
Catalog number
95301-M-17
Published
2016-09-22
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
NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153479000NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemNinepoint Medical, Inc.2016-02-16NQQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859591006065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859591006065008595910060658595910060650859591006065

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic optical coherence tomography system probeA sterile endoscopic device intended to scan cross-sectional images of tissues within non-vascular luminal structures [e.g., gastrointestinal tract (GI), urinary tract] at a microscopic level. It is a flexible fibreoptic bundle with a rotating distal end designed to emit a light beam whereby real-time, in-depth, high-resolution imagery is produced by means of volumetric laser endomicroscopy (VLE) technology; it may also provide tissue laser marking for visual referencing. It is inserted through the working channel of an endoscope and may be inflated in situ with an inflator; the proximal end connects to the system’s console. It may also be used ex-vivo. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter17Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-28 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
855-900-7199customerservice@ninepointmedical.com

Regulatory Flags#

DUNS number
961880999
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859591006232NvisionVLE Inflation Kit 96101-6096101-602016-09-22
00859591006249NvisionVLE Marking Console with IRIS94301-MI94301-MI2018-11-09
00859591006256NvisionVLE Marking Console with IRIS, Refurbished94301-MI-R94301-MI-R2018-11-09
00859591006263NvisionVLE Marking Console with IRIS, Upgraded94301-MI-UPG2018-11-09
00859591006270NvisionVLE Marking Console with IRIS, Upgraded, Refurbished94301-MI-UPG-R2018-11-09
00859591006027NvisionVLE Imaging Probe 14mm95101-1495101-142016-09-22
00859591006034NvisionVLE Imaging Probe 17mm95101-1795101-172016-09-22
00859591006041NvisionVLE Imaging Probe 20mm95101-2095101-202016-09-22
00859591006058NvisionVLE Marking Probe 14mm95301-M-1495301-M-142016-09-22
00859591006072NvisionVLE Marking Probe 20mm95301-M-2095301-M-202016-09-22
00859591006089NvisionVLE Imaging Console94101941012016-09-22
00859591006096NvisionVLE Imaging Console Refurbished 94101-R94101-R2016-09-22
00859591006102NvisionVLE Marking Console94301-M94301-M2016-09-22
00859591006119NvisionVLE Marking Console Refurbished94301-M-R94301-M-R2016-09-22
00859591006126NvisionVLE Marking Probe 17mm Clinical 95301-M-17C95301-M-17C2016-09-22
00859591006133NvisionVLE Marking Probe 20mm Clinical 95301-M-20C95301-M-20C2016-09-22
00859591006140NvisionVLE Marking Probe 14mm Clinical 95301-M-14C95301-M-14C2016-09-22
00859591006157NvisionVLE Imaging Probe 17mm Clinical95101-17C95101-17C2016-09-22
00859591006164NvisionVLE Imaging Probe 20mm Clinical95101-20C95101-20C2016-09-22
00859591006171NvisionVLE Imaging Probe 14mm Clinical95101-14C95101-14C2016-09-22

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