FDA UDI
In Commercial Distribution
🇺🇸 United States
MirusTM Ligating Clip
DI: 08904255225541
·
Model: VMLT-300
·
MERIL ENDO SURGERY PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- MirusTM Ligating Clip
- Primary DI
- 08904255225541
- Version / Model
- VMLT-300
- Company Name
- MERIL ENDO SURGERY PRIVATE LIMITED
- Labeler DUNS
- 870914838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2026-04-18
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- e5660904-65a4-4d44-aa28-9372f2807c9e
Device Description
"Mirus™ Ligating clip are sterile, single use, implantable device made of implant grade titanium (ISO 5832-2 / ASTM F 67) that are intended for general surgical procedures that require vessel or tissue ligation. Mirus™ Ligating clips are supplied with multiuse non sterile Mirus™ Ligating Clip applier, allowing the end user to ligate a wide range of vessels and tissue TM structures, using the Mirus Ligating clips."
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 Safe
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 18904255225548 | GS1 | ||||
| Primary | 08904255225541 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200166 | 000 |