FDA UDI
In Commercial Distribution
🇺🇸 United States
FastClamp - FastClamp System
DI: 05051986011530
·
Model: A-1001
·
SURGICAL INNOVATIONS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FastClamp - FastClamp System
- Primary DI
- 05051986011530
- Version / Model
- A-1001
- Company Name
- SURGICAL INNOVATIONS LIMITED
- Labeler DUNS
- 771051935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-13
- Public Version
- 4
- Public Version Date
- 2020-04-01
- Public Version Status
- Update
- Public Device Record Key
- 8c9c0fc2-0a3c-4621-b333-3e3264d7c349
Device Description
Bariatric Fastclamp
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37050 | Medical table clamp | A device that is designed to be used together with operating tables and certain kinds of examination/treatment tables. It can have different fixation/locking mechanisms, but is often designed to fit onto the side rails of such tables. It is used to hold different components and accessories onto the table providing added functionality. Such devices can be footrests, transducer holders, anaesthesia screen holders. The clamp allows for easy and safe adjustments of the position of these accessory devices and provides a secure locking mechanism. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051986011530 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100442 | 000 |