FDA UDI
In Commercial Distribution
🇺🇸 United States
Laschal Surgical
DI: B659TFR0
·
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
- B659TFR0
- Version / Model
- 1
- Catalog Number
- TF-R
- Company Name
- LASCHAL SURGICAL INSTRUMENTS, INC
- Labeler DUNS
- 098488463
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-26
- Public Version
- 2
- Public Version Date
- 2023-02-24
- Public Version Status
- Update
- Public Device Record Key
- 0d54d7c2-58b4-4a90-bf82-c31320ac973d
Device Description
15.1cm Tunneling Forceps Castroviejo Lock Diamond Flat Handle 75' E/W Angle, Curved Right Blunt Tips
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 |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58344 | Tunnelling forceps | A hand-held manual surgical instrument designed to be used to open a soft tissue plane (tunnelling) and to pull an object, typically a tube implant or other device, back through the tunnel. It is made of metal and typically has an elongated, slender, scissors-like design with two blades that close like jaws and ring handles. It may be used during rib/rib cage internal fixation procedures. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B659TFR0 | HIBCC |