Mayo Hegar Needle Holder
Basic Information
- Brand Name
- Mayo Hegar Needle Holder
- Primary DI
- G20219063421416
- Version / Model
- 190634214
- Catalog Number
- 19-06342-14
- Company Name
- CONCISE ENTERPRISES
- Labeler DUNS
- 645816062
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-08
- Public Version
- 1
- Public Version Date
- 2023-04-17
- Public Version Status
- New
- Public Device Record Key
- 691aa2c4-34a6-43da-8f27-55f7ac5b133c
Device Description
The Mayo Hegar Needle Holder is a surgical instrument used to hold and guide needles during surgical procedures. It is a handheld instrument with a scissor-like design that features elongated, tapered jaws with serrated inner surfaces. The needle holder is typically made of high-quality stainless steel, which is durable and easy to clean. It may also feature tungsten carbide inserts on the jaws to provide a better grip on the needle and improve durability. The Mayo Hegar Needle Holder comes in various sizes, with the most common being between 5 and 7 inches long. It is important to choose the appropriate size and type of needle holder based on the specific surgical procedure being performed. Overall, the Mayo Hegar Needle Holder is an essential instrument in surgical settings and is used to securely grasp and manipulate needles during suturing or other procedures. Its design and construction are intended to provide optimal functionality, precision, and durability in medical contexts.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12726 | Suturing needle holder, reusable | A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G20219063421416 | HIBCC |