FDA UDI
In Commercial Distribution
🇺🇸 United States
XprESS Ultra
DI: 00857326005147
·
Model: MSB&LLF
·
STRYKER CORPORATION
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- XprESS Ultra
- Primary DI
- 00857326005147
- Version / Model
- MSB&LLF
- Catalog Number
- ULF-206
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-27
- Public Version
- 9
- Public Version Date
- 2026-01-12
- Public Version Status
- Update
- Public Device Record Key
- c983a217-cd78-4577-a127-1ccea5b5a071
Device Description
ENT Dilation System 6x8mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | 874.4420 | 1 |
| PNZ | Eustachian Tube Balloon Dilation Device | Ear, Nose, Throat | 874.4180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10718 | Eustachian catheter, single-use | A 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. | No | Active |
| 48140 | Nasal/paranasal balloon catheter, non-tracking | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857326005147 | GS1 | ||||
| Package | 10857326005144 | GS1 | Shelf Box | 1 | In Commercial Distribution |