FDA.reportPublic FDA data

XprESS Ultra

Primary DI
00857326005116
Brand
XprESS Ultra
Company
STRYKER CORPORATION
Model
MSB&LLF
Catalog number
ULF-105
Device description
ENT Dilation System 5x20mm
Published
2017-11-27
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

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical
PNZEustachian Tube Balloon Dilation Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1
PNZEustachian Tube Balloon Dilation DeviceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163509000XprESS ENT Dilation SystemEntellus Medical, Inc.2017-04-05PNZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857326005113PackageGS11In Commercial Distribution
00857326005116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085732600511310857326005113
00857326005116008573260051168573260051160857326005116

GMDN Terms#

Term, Definition table
TermDefinition
Nasal/paranasal balloon catheterA sterile flexible tube with an inflatable balloon at its distal tip designed to gently restructure nasal passages and dilate obstructed sinus ostia during a surgical procedure (sinuplasty), typically to treat sinusitis, and/or to gently restructure nasal passages to temporarily relieve nasal obstruction/congestion. The device typically consists of a single-lumen tube with a connector at the proximal end for attachment to an inflation device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327117189Neptune07030460000703-046-0002016-09-23
07613327117196Neptune07030460010703-046-0012016-09-23
07613327117202Neptune07030470000703-047-0002016-09-23
07613327117219Neptune07030470010703-047-0012016-09-23
07613327297799Neptune0703-165-0010703-165-0012016-09-23
07613327297805Neptune0703-120-0050703-120-0052016-09-23
07613327297812Neptune0703-007-0700703-007-0702016-09-23
07613327297829Neptune0703-165-0000703-165-0002016-09-23
07613327297836Neptune0703-125-0020703-125-0022016-09-23
07613327297843Neptune0703-070-0010703-070-0012016-09-23
07613327297850Neptune0703-216-0080703-216-0082016-09-23
07613327297867Neptune0703-320-0200703-320-0202016-09-23
07613327297874Neptune0703-216-0180703-216-0182016-09-23
07613327297881Neptune0703-213-0150703-213-0152016-09-23
07613327297898Neptune0703-320-0150703-320-0152016-09-23
07613327297904Neptune0703-310-0100703-310-0102016-09-23
07613327297911Neptune0703-070-0000703-070-0002016-09-23
07613327297928Neptune0703-125-0010703-125-0012016-09-23
07613327297935Neptune0703-620-0200703-620-0202016-09-23
07613327297942Neptune0703-213-0200703-213-0202016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B382SD9200321000Surgical DirectSurgical Direct, Inc.LRC2026-07-29
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B382SD9200321070Surgical DirectSurgical Direct, Inc.LRC2026-07-29
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