FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Linear Cutter Staplers and Reloads
DI: 06946480576151
·
Model: DCR B-80B
·
Sinolinks Medical Innovation Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Linear Cutter Staplers and Reloads
- Primary DI
- 06946480576151
- Version / Model
- DCR B-80B
- Company Name
- Sinolinks Medical Innovation Co., Ltd.
- Labeler DUNS
- 528192598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-04
- Public Version
- 1
- Public Version Date
- 2025-09-12
- Public Version Status
- New
- Public Device Record Key
- ed45b6ae-c4e9-4b9a-b05c-e1788c3448db
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 59870 | Open-surgery manual linear cutting stapler, single-use | A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06946480576151 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131511 | 000 |