FDA UDI
In Commercial Distribution
🇺🇸 United States
CleanCision™ Wound Retraction and Protection System
DI: 00868532000307
·
Model: FG 0001
·
PRESCIENT SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CleanCision™ Wound Retraction and Protection System
- Primary DI
- 00868532000307
- Version / Model
- FG 0001
- Catalog Number
- CC-S
- Company Name
- PRESCIENT SURGICAL, INC.
- Labeler DUNS
- 078503474
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-15
- Public Version
- 4
- Public Version Date
- 2020-05-29
- Public Version Status
- Update
- Public Device Record Key
- dbd9a912-8c34-4805-be2e-207e9f58e71f
Device Description
The CleanCision Wound Retraction and Protection System is a sterile, single-use device, which integrates controlled fluid delivery, wound barrier protection and surgical retraction.
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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PQI | Wound Retraction And Protection System | General, Plastic Surgery | 878.4371 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47431 | Radial surgical retractor | A sterile surgical device intended to be inserted across a surgical incision to separate the margins of the incision to create a conduit to the underlying organs/tissues during hand-assisted minimally-invasive and open surgery. It consists of an external and internal fixed or retracting ring interconnected with an elastomeric sleeve/sheath intended to also provide protection against wound contamination, and may include channels/tubing to allow wound-edge irrigation. Also known as a lap disc, hand access device, handport, or protector, it may be used with or without a seal cap for colorectal, urological, gynaecological, or general abdominal surgical procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00868532000314 | GS1 | Shelf Carton | 4 | In Commercial Distribution | |
| Primary | 00868532000307 | GS1 |
Customer Contacts
- Phone
- 650-999-0263
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172132 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3 to 9 cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool, dry environment