FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PhotonGuide XT System
DI: 00816728020110
·
Model: Narrow / Angled
·
INVUITY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PhotonGuide XT System
- Primary DI
- 00816728020110
- Version / Model
- Narrow / Angled
- Catalog Number
- 104001XT
- Company Name
- INVUITY, INC.
- Labeler DUNS
- 175697908
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2020-04-24
- Public Version Status
- Update
- Public Device Record Key
- c16a5c0d-924b-4047-81db-bddda2b4bcd9
- Distribution End Date
- 2019-01-02
Device Description
The PhotonGuide XT System is intended to provide surgical site illumination from a high intensity light source.
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
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | 876.4530 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48036 | Surgical instrument fibreoptic light | A sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816728020110 | GS1 |
Customer Contacts
- Phone
- 8667117768
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Angle: Angled | ||
| Device Size Text, specify | Width: Narrow |