FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Lariat
DI: M95530050
·
Model: III
·
SENTREHEART, INC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Lariat
- Primary DI
- M95530050
- Version / Model
- III
- Catalog Number
- 3005
- Company Name
- SENTREHEART, INC
- Labeler DUNS
- 068810802
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4d15f3f8-da72-4798-b0e1-21470137e67f
- Distribution End Date
- 2018-02-20
Device Description
Suture Delivery Device
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | 878.4800 | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 878.5000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62314 | Open-surgery ligature loop | A sterile implantable suture-loop intended to be used to constrict (ligate) or approximate tissue during an open-surgical procedure. The ligature is made of polyester material and is typically pre-knotted. It is applied using a dedicated, disposable, hand-held ligator (included) which allows access to difficult areas, and which may be used with a dedicated guide sheath (not included). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M95530050 | HIBCC |
Customer Contacts
- Phone
- 1-855-256-7330
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142241 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 45 | Millimeter |