Identity
- Trade Name
- Mayo Hegar Needle Holder FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 190634214 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 19-06342-14 FDA UDI
- Primary DI / UDI-DI
- G20219063421416 FDA UDI
- FDA Product Code
- FHQ FDA UDI
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suturing needle holder, reusable
Mayo Hegar Needle Holder by Concise Enterprises — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Concise Enterprises
Sources (1)
- FDA UDI 691aa2c4-34a6-43da-8f27-55f7ac5b133c 34 fields · synced May 31, 2026