FDA UDI
In Commercial Distribution
🇺🇸 United States
Front1 Health Partners
DI: 07290110065997
·
Model: 11006802480F1
·
DEGANIA SILICONE LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Front1 Health Partners
- Primary DI
- 07290110065997
- Version / Model
- 11006802480F1
- Company Name
- DEGANIA SILICONE LTD
- Labeler DUNS
- 600007082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-20
- Public Version
- 1
- Public Version Date
- 2024-02-28
- Public Version Status
- New
- Public Device Record Key
- 5391edca-6d3c-4559-b67e-69b6e2a2b27f
Device Description
Straight silicone wound drain 24Fr
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | 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 |
|---|---|---|---|---|---|---|
| Package | 27290110065991 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 07290110065997 | GS1 | ||||
| Package | 47290110065995 | GS1 | 10 | In Commercial Distribution |