De Soutter Medical
LINDEMANN DRILL 2.2mm x 68mm STRYKER EQUIV. 1608-2-43
7manufacturers in China registered for this device type
143catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Zonefly Medical Devices Co., Ltd. | Danyang | Jiangsu | Specification developer | 7 |
| Jiangxi Vision Plus Medical Technology Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
Record
| Listed by | DE Soutter Medical Ltd., United Kingdom |
|---|---|
| FDA product code | GFF |
| Device type | Bur, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-29 |
| Record revised | 2023-06-27 (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, expiry date, manufacturing date |
| Packaging | Box of 5 |
| Distribution end date | 2025-10-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R60-509 | In distribution | |
| H51-0550 | In distribution | |
| R60-535 | In distribution | |
| R12-106 | In distribution | |
| R25-307 | In distribution | |
| R15-309 | In distribution | |
| H50-1140 | In distribution | |
| R15-207 | In distribution | |
| R16-202 | In distribution | |
| R60-534 | In distribution | |
| R11-304 | In distribution | |
| R25-204 | In distribution | |
| R15-208 | In distribution | |
| R11-105 | In distribution | |
| R16-101 | In distribution | |
| R52-208 | In distribution | |
| R15-209 | In distribution | |
| R60-506 | In distribution | |
| R25-208 | In distribution | |
| H50-0560 | In distribution | |
| R16-302 | In distribution | |
| R11-205 | In distribution | |
| R15-204 | In distribution | |
| H50-0570 | In distribution | |
| R52-320 | In distribution | |
| R15-308 | In distribution | |
| R13-103 | In distribution | |
| H51-1130 | In distribution | |
| H50-0760 | In distribution | |
| R12-102 | In distribution | |
| R60-516 | In distribution | |
| R14-104 | In distribution | |
| H51-1120 | In distribution | |
| H51-0760 | In distribution | |
| R11-207 | In distribution | |
| R12-204 | In distribution | |
| R25-108 | In distribution | |
| R60-549 | In distribution | |
| R11-210 | In distribution | |
| R52-420 | In distribution | |
| H51-0770 | In distribution | |
| R15-108 | In distribution | |
| H50-0950 | In distribution | |
| R15-107 | In distribution | |
| R12-206 | In distribution | |
| R60-520 | In distribution | |
| R15-201 | In distribution | |
| H57-1618 | In distribution | |
| R60-101 | In distribution | |
| R60-201 | In distribution | |
| H50-0930 | In distribution | |
| H54-0730 | In distribution | |
| R52-312 | In distribution | |
| R60-536 | In distribution | |
| R16-201 | In distribution | |
| R25-308 | In distribution | |
| R52-212 | In distribution | |
| R25-304 | In distribution | |
| H51-0720 | In distribution | |
| R15-106 | In distribution | |
| H51-0530 | In distribution | |
| R13-105 | In distribution | |
| R25-209 | In distribution | |
| H50-0770 | In distribution | |
| R15-109 | In distribution | |
| R11-208 | In distribution | |
| H50-0750 | In distribution | |
| R11-301 | In distribution | |
| R12-104 | In distribution | |
| R11-209 | In distribution | |
| R60-504 | In distribution | |
| H54-1130 | In distribution | |
| H50-0740 | In distribution | |
| H50-1130 | In distribution | |
| R15-103 | In distribution | |
| H50-0730 | In distribution | |
| H57-1218 | In distribution | |
| R25-207 | In distribution | |
| H50-0550 | In distribution | |
| R15-210 | In distribution | |
| R14-307 | In distribution | |
| R15-105 | In distribution | |
| R25-210 | In distribution | |
| R52-413 | In distribution | |
| NR12-105 | In distribution | |
| H53-0550 | In distribution | |
| R13-109 | In distribution | |
| R13-108 | In distribution | |
| H50-0720 | In distribution | |
| R25-110 | In distribution | |
| R16-102 | In distribution | |
| R15-115 | In distribution | |
| R15-101 | In distribution | |
| R11-203 | In distribution | |
| R15-307 | In distribution | |
| H51-0510 | In distribution | |
| R11-206 | In distribution | |
| R60-528 | In distribution | |
| H50-1150 | In distribution | |
| R15-110 | In distribution | |
| R13-106 | In distribution | |
| R25-104 | In distribution | |
| R15-304 | In distribution | |
| R15-202 | In distribution | |
| R60-510 | In distribution | |
| R12-105 | In distribution | |
| H53-0750 | In distribution | |
| R12-107 | In distribution | |
| R15-104 | In distribution | |
| R15-102 | In distribution | |
| H51-0740 | In distribution | |
| H51-0730 | In distribution | |
| R16-301 | In distribution | |
| H50-1160 | In distribution | |
| R14-207 | In distribution | |
| H51-0520 | Withdrawn | |
| H51-0710 | Withdrawn | |
| H51-0540 | Withdrawn | |
| H51-0560 | Withdrawn | |
| R52-101 | Withdrawn | |
| H51-0750 | Withdrawn | |
| H53-0760 | Withdrawn | |
| H51-0910 | Withdrawn | |
| H51-0920 | Withdrawn | |
| H50-0710 | Withdrawn | |
| H50-0540 | Withdrawn | |
| H50-0520 | Withdrawn | |
| H51-0506 | Withdrawn | |
| R27-110 | Withdrawn | |
| H54-0930 | Withdrawn | |
| H55-0710 | Withdrawn | |
| H50-0510 | Withdrawn | |
| H51-0570 | Withdrawn | |
| R14-107 | Withdrawn | |
| H51-1110 | Withdrawn | |
| R25-309 | Withdrawn | |
| H51-0930 | Withdrawn | |
| H50-0940 | Withdrawn | |
| R13-102 | Withdrawn | |
| R13-209 | Withdrawn | |
| H50-0960 | Withdrawn | |
| R13-208 | Withdrawn | |
| H50-0530 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Komet Surgical Bur | Gebr. Brasseler Gmbh & Co. KG | 1,011 |
| Bur, Surgical, General & Plastic Surgery | Sterilmed, Inc. | 1,001 |
| Medline | Medline Industries, Inc. | 584 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 335 |
| Bur, Surgical, General & Plastic Surgery | Omega Surgical Instruments, Inc. | 312 |
| Bur, Surgical, General & Plastic Surgery | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 170 |
| MicroAire® | Microaire Surgical Instruments LLC | 162 |
| Ultrapower | ConMed Corporation | 155 |
| Jota | Jota AG | 112 |
| Conmed | ConMed Corporation | 109 |
| Bur, Round, round shank | Gebr. Brasseler Gmbh & Co. KG | 104 |
| Stryker | Provision | 97 |
Showing 12 of 167. All products under Bur, Surgical, General & Plastic Surgery
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.