Aesculap
LANDOLT-REULEN Pituitary Raspatory, 10 1/4", (260 mm), working length: 6 1/8", (155 mm), diam. 2,20 mm, bayonet-shaped, sharp, roundhandle, non-sterile, reusable
12manufacturers in China registered for this device type
61catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Guangdong (3), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | HTR |
| Device type | Rasp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-22 |
| Record revised | 2023-08-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2022-03-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FK328R | In distribution | |
| FK300R | In distribution | |
| DO773R | In distribution | |
| FK356R | In distribution | |
| FK532R | In distribution | |
| FF640R | In distribution | |
| FF619R | In distribution | |
| FK350R | In distribution | |
| DO553R | In distribution | |
| FK301R | In distribution | |
| OG161R | In distribution | |
| OL161R | In distribution | |
| FK310R | In distribution | |
| FK543R | In distribution | |
| OM311R | In distribution | |
| FK390R | In distribution | |
| FK345R | In distribution | |
| DO530R | In distribution | |
| DO523R | In distribution | |
| FK348R | In distribution | |
| OL143R | In distribution | |
| DO772R | In distribution | |
| OL230R | In distribution | |
| FK357R | In distribution | |
| DO552R | In distribution | |
| FK541R | In distribution | |
| FK534R | In distribution | |
| FK299R | In distribution | |
| GC623R | In distribution | |
| FK344R | In distribution | |
| FK303R | In distribution | |
| FK314R | In distribution | |
| FK355R | In distribution | |
| OG162R | In distribution | |
| FK341R | In distribution | |
| FK394R | In distribution | |
| OL140R | In distribution | |
| FK360R | In distribution | |
| FK552R | In distribution | |
| FF641R | In distribution | |
| OM314R | In distribution | |
| FK530R | In distribution | |
| FK329R | In distribution | |
| OL180R | In distribution | |
| FK308R | In distribution | |
| FK307R | In distribution | |
| OL231R | In distribution | |
| FK359R | In distribution | |
| FK302R | In distribution | |
| FK351R | In distribution | |
| OM315R | In distribution | |
| FK309R | In distribution | |
| DO771R | In distribution | |
| FK340R | In distribution | |
| OL142R | In distribution | |
| OL141R | In distribution | |
| FK353R | In distribution | |
| FK306R | In distribution | |
| FK358R | In distribution | |
| DO532R | Withdrawn | |
| FK352R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 240 |
| TiWAVE C Cervical Cage System | Kalitec Direct, LLC | 232 |
| Tranquil-C™ | Nexus Spine, L.L.C. | 158 |
| Calix Spinal Implant System | Xtant Medical Holdings, Inc. | 143 |
| Rasp | Medtronic Sofamor Danek, Inc. | 109 |
| Specials | Seaspine Orthopedics Corporation | 109 |
| Stryker | Avalign Technologies, Inc. | 105 |
| Endoskeleton® TAS | Medtronic Sofamor Danek, Inc. | 93 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 90 |
| Cambria | Seaspine Orthopedics Corporation | 85 |
| IdentiTi | Alphatec Spine, Inc. | 83 |
| Link Instruments – Rasps, compressors and broaches | Waldemar Link GmbH & Co. KG | 83 |
Showing 12 of 378. All products under Rasp
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.