FDA UDI
In Commercial Distribution
🇺🇸 United States
LIGACLIP
DI: 10705036012801
·
Model: LT200
·
ETHICON ENDO-SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- LIGACLIP
- Primary DI
- 10705036012801
- Version / Model
- LT200
- Catalog Number
- LT200
- 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
- 5
- Public Version Date
- 2023-11-06
- Public Version Status
- Update
- Public Device Record Key
- c3f5e549-2523-427d-8fe9-aec8d14d7577
Device Description
LIGACLIP EXTRA Ligating Clip Cartridges: 6 Titanium Clips/ Cartridge (Medium)
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 |
|---|---|---|---|---|
| FZP | CLIP, IMPLANTABLE | General, Plastic Surgery | 878.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35649 | Ligation clip, metallic | A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40705036012802 | GS1 | CASE | 864 | In Commercial Distribution | |
| Primary | 10705036012801 | GS1 | ||||
| Package | 20705036012808 | GS1 | BOX | 36 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K830503 | 000 |