FDA UDI
In Commercial Distribution
🇺🇸 United States
Eigr™ Saber Waveguide
DI: 00816728020011
·
Model: Yankauer, Fin Tip
·
INVUITY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Eigr™ Saber Waveguide
- Primary DI
- 00816728020011
- Version / Model
- Yankauer, Fin Tip
- Catalog Number
- ES2Y
- Company Name
- INVUITY, INC.
- Labeler DUNS
- 175697908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-12
- Public Version
- 5
- Public Version Date
- 2020-04-24
- Public Version Status
- Update
- Public Device Record Key
- 8b593c78-e1b8-4739-9423-5d5217e97def
Device Description
The Invuity Eigr Saber Waveguide with Yankauer is intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| JOL | Catheter And Tip, Suction | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38518 | Surgical/emergency suction cannula, illuminating, single-use | An atraumatic, invasive, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or clear an airway obstruction, whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic, nor an intravascular device; it is not designed for surgical irrigation. It has a built-in light or fibreoptic bundle used to illuminate the operative site. Often referred to a as suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816728020011 | GS1 |
Customer Contacts
- Phone
- 8667117768
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tip: Fin |