FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgical Direct
DI: B382SD492298C0250
·
Model: SD49229-8C025
·
Surgical Direct, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Surgical Direct
- Primary DI
- B382SD492298C0250
- Version / Model
- SD49229-8C025
- Catalog Number
- SD49229-8C025
- Company Name
- Surgical Direct, Inc.
- Labeler DUNS
- 124367223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-15
- Public Version
- 1
- Public Version Date
- 2024-11-25
- Public Version Status
- New
- Public Device Record Key
- c447d2c3-52fe-40ac-beb8-4bbfaa48c603
Device Description
8mm Sheath for Tunneler Stainless Steel 25 cm Full Curved
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35952 | Helicopter ambulance | A helicopter designed (modified and equipped) for use by emergency medical services (EMS) to transport the sick or wounded, especially as a rapid alternative to ground transport around urban areas or during military operations. It will carry onboard equipment for emergency treatment and to maintain or improve the clinical status of the patient, such as devices for carrying or supporting a patient (e.g., stretchers, splints), oxygen therapy (e.g., oxygen cylinders and tubing), intubation/chest decompression (tubes), bleeding control (e.g., bandages, tourniquets), cardioversion/defibrillation (defibrillators), and patient monitoring. It may also carry tools to help extricate a trapped patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B382SD492298C0250 | HIBCC |
Customer Contacts
- Phone
- +1 (800) 519-3293
- [email protected]