ACE
BUR Trephine 47TL 4.25ID 5.1OD 18.5CL SN Mrks 8-10-13-15-18MM TI Internal Irrigation
6manufacturers in China registered for this device type
58catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
Record
| Listed by | Ace Surgical Supply Co., Inc., United States |
|---|---|
| FDA product code | HWK |
| Device type | Trephine |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2019-10-12 |
| Record revised | 2020-06-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Sizes | Outer diameter 2.8 to 10.9 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04949202ST | Outer Diameter 5.1 mm | In distribution |
| 04949501ST | Outer Diameter 6.9 mm | In distribution |
| 04942015 | Outer Diameter 4.25 mm | In distribution |
| 04942212 | Outer Diameter 6 mm | In distribution |
| 04942211 | Outer Diameter 5 mm | In distribution |
| 04942025 | Outer Diameter 4.25 mm | In distribution |
| 04942011 | Outer Diameter 2.8 mm | In distribution |
| 04948401 | Outer Diameter 6.1 mm | In distribution |
| 04942222 | Outer Diameter 6 mm | In distribution |
| 04948501 | Outer Diameter 6.9 mm | In distribution |
| 04948401 | Outer Diameter 6.1 mm | In distribution |
| 04942003 | Outer Diameter 3.5 mm | In distribution |
| 04949501S | Outer Diameter 6.9 mm | In distribution |
| 04942212 | Outer Diameter 6 mm | In distribution |
| 04949202 | Outer Diameter 5.1 mm | In distribution |
| 04948202 | Outer Diameter 5.1 mm | In distribution |
| 04942202 | Outer Diameter 6 mm | In distribution |
| 04949501 | Outer Diameter 6.9 mm | In distribution |
| 04942022 | Outer Diameter 3.2 mm | In distribution |
| 04948001 | Outer Diameter 2.8 mm | In distribution |
| 04948702 | Outer Diameter 10.8 mm | In distribution |
| 04942001 | Outer Diameter 2.8 mm | In distribution |
| 04942021 | Outer Diameter 2.8 mm | In distribution |
| 04942211 | Outer Diameter 5 mm | In distribution |
| 04942221 | Outer Diameter 5 mm | In distribution |
| 04942002 | Outer Diameter 3.2 mm | In distribution |
| 04941001 | In distribution | |
| 04942024 | Outer Diameter 4 mm | In distribution |
| 04942201 | Outer Diameter 5 mm | In distribution |
| 04942202 | Outer Diameter 6 mm | In distribution |
| 04942201 | Outer Diameter 5 mm | In distribution |
| 04948501 | Outer Diameter 6.9 mm | In distribution |
| 04948002 | Outer Diameter 3.5 mm | In distribution |
| 04948502 | Outer Diameter 7.9 mm | In distribution |
| 04948502 | Outer Diameter 7.9 mm | In distribution |
| 04948201 | Outer Diameter 4.6 mm | In distribution |
| 04942221 | Outer Diameter 5 mm | In distribution |
| 04942014 | Outer Diameter 4 mm | In distribution |
| 04942004 | Outer Diameter 4 mm | In distribution |
| 04942025 | Outer Diameter 4.25 mm | In distribution |
| 04949202S | Outer Diameter 5.1 mm | In distribution |
| 04949201 | Outer Diameter 4.6 mm | In distribution |
| 04949702S | Outer Diameter 10.9 mm | In distribution |
| 04948202 | Outer Diameter 5.1 mm | In distribution |
| 04948201 | Outer Diameter 4.6 mm | In distribution |
| 04942024 | Outer Diameter 4 mm | In distribution |
| 04942013 | Outer Diameter 3.5 mm | In distribution |
| 04948601 | Outer Diameter 6.9 mm | In distribution |
| 04942023 | Outer Diameter 3.5 mm | In distribution |
| 04948701 | Outer Diameter 8.9 mm | In distribution |
| 04948002 | Outer Diameter 3.5 mm | In distribution |
| 04948602 | Outer Diameter 7.9 mm | In distribution |
| 04949201ST | Outer Diameter 4.6 mm | In distribution |
| 0494512 | In distribution | |
| 04948001 | Outer Diameter 2.8 mm | In distribution |
| 04949702ST | Outer Diameter 10.9 mm | In distribution |
| 04942222 | Outer Diameter 6 mm | In distribution |
| 04949702 | Outer Diameter 10.9 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Shukla Trephine S9TREPHINE | Shukla Medical | 42 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 40 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 28 |
| IdentiTi | Alphatec Spine, Inc. | 22 |
| Zoll-Dental | Zoll-Dental | 20 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 17 |
| Trephine | Synthes Gmbh | 15 |
| Trephine | KLS-Martin L.P. | 14 |
| Moreland | Depuy Orthopaedics, Inc. | 14 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 13 |
| Bradshaw Medical Inc. | Bradshaw Medical Inc. | 13 |
| Fassier-Duval Telescopic IM System | Orthopediatrics Canada ULC | 10 |
Showing 12 of 138. All products under Trephine
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.