FDA UDI
In Commercial Distribution
🇺🇸 United States
easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
DI: 06925776123491
·
Model: R45C
·
Ezisurg Medical Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
- Primary DI
- 06925776123491
- Version / Model
- R45C
- Catalog Number
- R45C
- Company Name
- Ezisurg Medical Co., Ltd.
- Labeler DUNS
- 421348845
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-07
- Public Version
- 2
- Public Version Date
- 2026-02-10
- Public Version Status
- Update
- Public Device Record Key
- 8132099a-4a28-4eab-bcb5-07a149ff609d
Device Description
Loading Units, 45±2mm Long, 3.8±0.2mm height, gold
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
- 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 |
|---|---|---|---|---|
| 59871 | Endoscopic manual linear cutting stapler, single-use | A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecologic, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) 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 |
|---|---|---|---|---|---|---|
| Package | 66925776123493 | GS1 | color box | 6 | In Commercial Distribution | |
| Primary | 06925776123491 | GS1 | ||||
| Package | 76925776123490 | GS1 | traveling case | 3 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172960 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius