FDA UDI
In Commercial Distribution
🇺🇸 United States
Laschal Surgical
DI: B659SC10
·
Model: 1
·
LASCHAL SURGICAL INSTRUMENTS, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Laschal Surgical
- Primary DI
- B659SC10
- Version / Model
- 1
- Catalog Number
- SC-1
- Company Name
- LASCHAL SURGICAL INSTRUMENTS, INC
- Labeler DUNS
- 098488463
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-01
- Public Version
- 2
- Public Version Date
- 2023-02-24
- Public Version Status
- Update
- Public Device Record Key
- 7a650859-496d-44da-acaf-0fd32d1a276b
Device Description
17.75cm Suture 3/0-8/0 Suture Cutter Castroviejo Round Handle Straight
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRW | Scissors, General, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16224 | Suture cutter, reusable | A dedicated hand-held surgical instrument designed for cutting sutures. It will typically have a protected scalpel-like blade which may be fixed or have a scissors-like cutting action. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B659SC10 | HIBCC |