FDA UDI
In Commercial Distribution
🇺🇸 United States
SureForm
DI: 00886874117088
·
Model: 48345B
·
INTUITIVE SURGICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SureForm
- Primary DI
- 00886874117088
- Version / Model
- 48345B
- Company Name
- INTUITIVE SURGICAL, INC.
- Labeler DUNS
- 938647021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-15
- Public Version
- 3
- Public Version Date
- 2020-03-02
- Public Version Status
- Update
- Public Device Record Key
- 882ccc1d-e968-4783-8e3c-40fe49871979
Device Description
SUREFORM 45 RELOAD BLUE
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 Conditional
- 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 |
|---|---|---|---|---|
| 35615 | Surgical staple loading unit, non-cutting | A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10886874117085 | GS1 | BOX | 12 | In Commercial Distribution | |
| Primary | 00886874117088 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 3.5 | Millimeter |