FDA UDI
In Commercial Distribution
🇺🇸 United States
WIKI Drain, 15 Fr, 3 cm, 6 Drains
DI: 00861838000347
·
Model: WIK-15-3-6
·
TOOLS FOR SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WIKI Drain, 15 Fr, 3 cm, 6 Drains
- Primary DI
- 00861838000347
- Version / Model
- WIK-15-3-6
- Catalog Number
- WIK-15-3-6
- Company Name
- TOOLS FOR SURGERY, LLC
- Labeler DUNS
- 841842441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-17
- Public Version
- 1
- Public Version Date
- 2023-07-25
- Public Version Status
- New
- Public Device Record Key
- 660bf5cb-f7a6-4311-b65e-346b7ac0a2e8
Device Description
The WIKI Drain is a flanged quadruple-lumen silicone channel drain. Package contains 6, 15 Fr, 3 cm drains.
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
- 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 |
|---|---|---|---|---|
| GBX | Catheter, Irrigation | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38566 | Surgical capillary wound drain, non-luminal | A sterile device, without a lumen, designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically available as a corrugated drainage sheet or ribbon made of non-latex materials [e.g., polyvinyl chloride (PVC), silicone], and may include radiopaque markers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861838000347 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter | |
| Length | 3 | Centimeter |