FDA.reportPublic FDA data

XprESS Ultra

Primary DI
00857326005123
Brand
XprESS Ultra
Company
STRYKER CORPORATION
Model
MSB&LLF
Catalog number
ULF-106
Device description
ENT Dilation System 6x20mm
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
10857326005120PackageGS11In Commercial Distribution
00857326005123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085732600512010857326005120
00857326005123008573260051238573260051230857326005123

GMDN Terms#

Term, Definition table
TermDefinition
Eustachian catheter, single-useA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown through the device and into the middle ear. It is typically made of plastic. 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
07613327625172Steri-Shield04248010000424-801-0002025-02-21
07613327625257Steri-Shield04247212000424-721-2002025-02-21
07613327625288Steri-Shield04247412000424-741-2002025-02-21
07613327625295Steri-Shield04248211000424-821-1002025-02-21
07613327625332Steri-Shield04248212000424-821-2002025-02-21
07613327625349Steri-Shield04248312000424-831-2002025-02-21
07613327625363Steri-Shield04248512000424-851-2002025-02-21
07613327625370Steri-Shield04249210000424-921-0002025-02-21
07613327625387Steri-Shield04249410000424-941-0002025-02-21
07613327625394Steri-Shield04249510000424-951-0002025-02-21
07613327625400Steri-Shield04249310000424-931-0002025-02-21
07613327625417Steri-Shield04249412000424-941-2002025-02-21
07613327625424Steri-Shield04249311000424-931-1002025-02-21
07613327625431Steri-Shield04249211000424-921-1002025-02-21
07613327625448Steri-Shield04249312000424-931-2002025-02-21
07613327625455Steri-Shield04249512000424-951-2002025-02-21
07613327625462Steri-Shield04249212000424-921-2002025-02-21
07613327625479Steri-Shield04249511000424-951-1002025-02-21
07613327625486Steri-Shield04249411000424-941-1002025-02-21
07613327465655Neptune0703-046-0060703-046-0062019-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422653MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422660MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422684MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422462MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422523MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422585MillenniumAvalign Technologies, Inc.LRC2026-07-31
09348811102645INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
09348811102669INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
00198506093593ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093777ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093807ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093814ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
B382SD9200321000Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321060Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321070Surgical DirectSurgical Direct, Inc.LRC2026-07-29
00190776422080MillenniumAvalign Technologies, Inc.LRC2026-07-28
00198506092442ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092633ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092664ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092763ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092787ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092824ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093043ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093050ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093067ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093074ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093098ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093159ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093227ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506091896ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22