Punches, Nobel
Guided Soft Tissue Punch 6.0/WP 5/pkg
1manufacturer
6catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Omnia Medical, United States |
|---|---|
| FDA product code | EME |
| Device type | Punch, Biopsy, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 32.Z2002.00 | 5 | In distribution | |
| 32.Z2008.00 | 5 | In distribution | |
| 32.Z2006.00 | 5 | In distribution | |
| 32.Z2000.00 | 5 | In distribution | |
| 32.Z2004.00 | 5 | In distribution | |
| 32.Z2007.00 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 36 |
| Sklar Instruments | Sklar Corporation | 24 |
| Kohdent | Kohler Medizintechnik GmbH | 22 |
| Osung MND | Osung MND Co., Ltd. | 20 |
| Medline | Medline Industries, Inc. | 20 |
| Acu-Punch | Acuderm, Inc. | 17 |
| Gynex | Gynex Corporation | 13 |
| Exel Biopsy Punch | Exel Inc. | 11 |
| Shard | Applied Dental, Inc. | 9 |
| Biotanium | Basic Dental Implant Systems, Inc. | 7 |
| Salvin Stainless Steel Multi-Use Rotary Tissue Punch – 4mm | Salvin Dental Specialties, LLC | 5 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 4 |
Showing 12 of 64. All products under Punch, Biopsy, Surgical
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-03-30 | Class II | Vendor change control | Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016. | 276,901 units | 2023-11-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.