Avalign
- Primary DI
- 00190776210779
- Brand
- Avalign
- Company
- AVALIGN TECHNOLOGIES, INC.
- Model
- VM21-4814
- Device description
- Reverdin Needle number 4,
- Published
- 2021-11-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| GDL | NEEDLE, SUTURING, REUSABLE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00190776210779 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00190776210779 | 00190776210779 | 190776210779 | 0190776210779 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 792528510
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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| 00194613112509 | MSI Precision Specialty Instruments | Med Saver, Inc. | GDL | 2025-08-01 |
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| 00194613119874 | MSI Precision Specialty Instruments | Med Saver, Inc. | GDL | 2025-08-01 |
| 00194613119881 | MSI Precision Specialty Instruments | Med Saver, Inc. | GDL | 2025-08-01 |
| 00194613119898 | MSI Precision Specialty Instruments | Med Saver, Inc. | GDL | 2025-08-01 |
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| 00194613121129 | MSI Precision Specialty Instruments | Med Saver, Inc. | GDL | 2025-08-01 |
| 00194613121136 | MSI Precision Specialty Instruments | Med Saver, Inc. | GDL | 2025-08-01 |
| 00190776401764 | Millennium | Avalign Technologies, Inc. | GDL | 2025-06-13 |
| 00190776397715 | Millennium | Avalign Technologies, Inc. | GDL | 2025-05-16 |
| 00194613106218 | MSI Precision Specialty Instruments | Med Saver, Inc. | GDL | 2025-03-21 |
| 00194613114237 | MSI Precision Specialty Instruments | Med Saver, Inc. | GDL | 2025-03-21 |
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| 00194613119904 | MSI Precision Specialty Instruments | Med Saver, Inc. | GDL | 2025-03-21 |
| 00194613119928 | MSI Precision Specialty Instruments | Med Saver, Inc. | GDL | 2025-03-21 |
| 00190776390716 | Millennium | Avalign Technologies, Inc. | GDL | 2024-11-19 |
| 04049197022682 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | GDL | 2024-10-02 |
| 04049197022699 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | GDL | 2024-10-02 |
| 04049197455718 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | GDL | 2024-09-20 |
| 04049197455725 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | GDL | 2024-09-20 |
| 04049197466295 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | GDL | 2024-09-20 |
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