M-Close Kit
Basic Information
- Brand Name
- M-Close Kit
- Primary DI
- 00850009417022
- Version / Model
- 27-101
- Catalog Number
- 27-101
- Company Name
- New Wave Endo-Surgery Inc.
- Labeler DUNS
- 089533899
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 2
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- fb8cd1a3-d94c-4753-847d-2eb8d2113976
Device Description
The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device.As part of the M-Close convenience kit, a Nerve Block Needle is included for the administration of local anesthetic agents to provide regional and local anesthesia. A Telfa Antimicrobial, non-Adherent Pad is also provided in the kit for use as a primary dressing for the surgical incision.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57874 | Suturing unit, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850009417053 | GS1 | Single unit box | 1 | In Commercial Distribution | |
| Primary | 00850009417022 | GS1 | ||||
| Package | 00850009417060 | GS1 | 5 unit box | 5 | In Commercial Distribution | |
| Package | 00850009417107 | GS1 | Shipping carton | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 8887008890
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 12 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry environment