FDA UDI
In Commercial Distribution
🇺🇸 United States
LaproClose
DI: 10850067560194
·
Model: LCLOSE-300
·
Surgical Principals, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- LaproClose
- Primary DI
- 10850067560194
- Version / Model
- LCLOSE-300
- Catalog Number
- LCLOSE-300
- Company Name
- Surgical Principals, Inc
- Labeler DUNS
- 782873892
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-12-11
- Public Version
- 1
- Public Version Date
- 2025-12-19
- Public Version Status
- New
- Public Device Record Key
- 9d303442-f423-4531-a570-eb8bca66da7e
Device Description
LAPROCLOSE SUTURE PASSER, 180 MM SUTRURE PASSER, 14G, TWO BARIATRIC (XL) LENGTH GUIDES (10/12 MM & 15 MM) AND TWO TROCAR SWABS (5-8MM & 10-12 MM))
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| HWQ | Passer | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37839 | Suturing unit, reusable | A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850067560197 | GS1 | ||||
| Primary | 10850067560194 | GS1 |
Customer Contacts
- Phone
- 253-441-6509
- [email protected]