FDA UDI
In Commercial Distribution
🇺🇸 United States
30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging
DI: 00787551037029
·
Model: 30977
·
XODUS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging
- Primary DI
- 00787551037029
- Version / Model
- 30977
- Catalog Number
- 30977
- Company Name
- XODUS MEDICAL, INC.
- Labeler DUNS
- 868042664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 3
- Public Version Date
- 2023-01-20
- Public Version Status
- Update
- Public Device Record Key
- 4c18db6f-7e31-407d-8d29-a488bbd2e3a7
Device Description
30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & Defogging
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45225 | Endoscope antifog solution | A liquid substance intended to be used to prevent the occurrence of condensed vapour (fog) on the lens of an endoscopic instrument during treatment. It will typically be used on the lens of an endoscopic camera where the warmth from an enclosed body cavity creates the conditions to produce fog on the lens. This device will typically be contained in a spray can, bottle, or squeeze bottle. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20787551037023 | GS1 | CASE | 16 | In Commercial Distribution | |
| Primary | 00787551037029 | GS1 |
Customer Contacts
- Phone
- +1(724)337-5500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182080 | 000 |