FDA UDI
In Commercial Distribution
🇺🇸 United States
SureForm
DI: 00886874123652
·
Model: 436504
·
INTUITIVE SURGICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SureForm
- Primary DI
- 00886874123652
- Version / Model
- 436504
- Company Name
- INTUITIVE SURGICAL, INC.
- Labeler DUNS
- 938647021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-20
- Public Version
- 1
- Public Version Date
- 2025-06-30
- Public Version Status
- New
- Public Device Record Key
- 481b954a-9bca-435c-a652-0a06b5517cdf
Device Description
45mm Curved Tip Stapler
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAY | System, surgical, computer controlled instrument | Gastroenterology, Urology | 876.1500 | 2 |
| GDW | Staple, implantable | General, Plastic Surgery | 878.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63502 | Robotic surgical cutting stapler, single-use | A sterile electrically-powered surgical instrument intended to be used in conjunction with a robotic surgical system during a robotic endoscopic procedure for the expeditious transection and resection of tissues and the creation of anastomoses. The device is intended to mechanically cut the tissue and simultaneously apply surgical staples to the resulting sides of the cut line, with power from a motor. It is designed as a long shaft with a distal stapling mechanism designed to accept an endpiece/loading unit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10886874123659 | GS1 | BOX | 6 | In Commercial Distribution | |
| Primary | 00886874123652 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243596 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 45 | Millimeter | |
| Outer Diameter | 14 | Millimeter |