Identity
- Trade Name
- Needle Holder, Straight Jaw, 5cm WL FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Actuated Holder FDA UDI
- Model / Reference
- 07-828-11MA FDA UDI
- Description
- Actuated Holder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810009462934 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
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
A user-friendly and versatile needle holder designed for general use, suitable for various medical specialties. It features a straight jaw design with interchangeable jaws for optimal grip and control. The device is made of durable materials and is available in multiple sizes to accommodate different patient needs.
Similar devices
Also classified as Suturing needle holder, reusable.
- JACOBSON NEEDLE HOLDER — SONTEC INSTRUMENTS, INC. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
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- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- HNM Medical — HNM STAINLESS, LLC. · Class I
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
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
- Mizuho America, Inc.
Sources (1)
- FDA UDI ce22ecd6-83ce-465c-9f87-ef1a74ec6a66 33 fields · synced Oct 6, 2026