Ethmoid Pediatric Rongeur
Ethmoid Pediatric Rongeur Micro Jaws Angled UP 90 Degrees Quantum
3manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | KBB |
| Device type | Rongeur, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2019-03-25 |
| Record revised | 2026-06-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 3.75 to 4 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 468-590Q | Length 4 in | In distribution |
| 468-585 | Length 4 in | In distribution |
| 468-580 | 2.5 Millimeter Tip | In distribution |
| 468-580Q | Length 4 in | In distribution |
| 468-590 | 2.5 Millimeter Tip | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tri-D Kerrison Rongeur | Mizuho Corporation | 20 |
| Jedmed | Jedmed Instrument Company | 17 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 17 |
| Ambler Surgical | Ambler Surgical, LLC | 16 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 13 |
| Rongeur, Nasal | Biomet Microfixation | 11 |
| Integra® | Integra LifeSciences Production Corporation | 11 |
| Kerrison rongeur | Mizuho Corporation | 10 |
| Millennium | Avalign Technologies, Inc. | 9 |
| Marina Medical | Marina Medical Instruments, Inc. | 9 |
| Avalign | Avalign Technologies, Inc. | 9 |
| Rongeur | KLS-Martin L.P. | 9 |
Showing 12 of 33. All products under Rongeur, Nasal
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.