FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 10705036002826
·
Model: SR55
·
ETHICON ENDO-SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 10705036002826
- Version / Model
- SR55
- Catalog Number
- SR55
- Company Name
- ETHICON ENDO-SURGERY, LLC
- Labeler DUNS
- 044606982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-24
- Public Version
- 8
- Public Version Date
- 2023-11-06
- Public Version Status
- Update
- Public Device Record Key
- ee04a4e7-716f-45ed-8d56-0c1b1f2d3910
Device Description
Linear Cutter Reloads, 55mm Selectable -6 Rows
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
- 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 |
|---|---|---|---|---|
| GDW | STAPLE, IMPLANTABLE | General, Plastic Surgery | 878.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64256 | Surgical staple loading unit, cutting | A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) and an internal cutting blade designed to be used with a surgical stapler (not included) during endoscopic or open-surgery (e.g., bowel resection to create anastomoses). The unit is designed to deploy the staples (e.g., in a straight or circular row) while the blade cuts the adjacent tissue. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30705036002820 | GS1 | CASE | 144 | In Commercial Distribution | |
| Primary | 10705036002826 | GS1 | ||||
| Package | 20705036002823 | GS1 | BOX | 12 | In Commercial Distribution | |
| Package | 40705036002827 | GS1 | CASE | 192 | In Commercial Distribution | |
| Package | 50705036002824 | GS1 | CASE | 144 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092577 | 000 |