Stryker
97 catalogue numbers from 5820-110-30C, listed by Provision, under Bur, Surgical, General & Plastic Surgery. 7 manufacturers in China are registered for this product code.
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 | Provision |
|---|---|
| FDA product code | GFF |
| Device type | Bur, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Premarket notification | Exempt |
| Record published | 2023-07-06 |
| Record revised | 2025-02-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5820-110-30C | In distribution | |
| 5820-009-040 | In distribution | |
| 5820-110-50 | In distribution | |
| 5820-16-050 | In distribution | |
| 5820-13-050 | In distribution | |
| 8470-107-030 | In distribution | |
| 5820-10-160 | In distribution | |
| 5820-110-40 | In distribution | |
| 5820-107-130 | In distribution | |
| 5120-123-126 | In distribution | |
| 5120-10-50 | In distribution | |
| 5820-12-050 | In distribution | |
| 5820-107-430S1 | In distribution | |
| 5820-15-040 | In distribution | |
| 5540-12-20 | In distribution | |
| 5820-12-010 | In distribution | |
| 5820-009-030 | In distribution | |
| 5820-10-230 | In distribution | |
| 2296-100-423 | In distribution | |
| 2296-101-421 | In distribution | |
| 8470-107-525L | In distribution | |
| 1900-015-040 | In distribution | |
| 1900-010-040 | In distribution | |
| 5450-107-025 | In distribution | |
| 5230-107-330 | In distribution | |
| 5540-013-020 | In distribution | |
| 5300-30-511 | In distribution | |
| 5130-071-223S1 | In distribution | |
| 5820-10-120 | In distribution | |
| 8450-107-530 | In distribution | |
| 5820-107-20 | In distribution | |
| 5820-009-060 | In distribution | |
| 5820-13-140 | In distribution | |
| 5820-107-440 | In distribution | |
| 8470-009-030 | In distribution | |
| 5820-12-030 | In distribution | |
| 5820-10-150 | In distribution | |
| 8470-107-530 | In distribution | |
| 5220-30-560 | In distribution | |
| 5820-10-40 | In distribution | |
| 5820-12-330 | In distribution | |
| 5820-009-075 | In distribution | |
| 5130-71-23 | In distribution | |
| 2296-100-418 | In distribution | |
| 5820-10-250 | In distribution | |
| 5820-12-015 | In distribution | |
| 5820-110-30 | In distribution | |
| 5540-009-050 | In distribution | |
| 1900-015-040 | In distribution | |
| 5540-009-330 | In distribution | |
| 5540-012-330 | In distribution | |
| 5820-012-315 | In distribution | |
| 5820-15-050 | In distribution | |
| 5820-13-130 | In distribution | |
| 5540-010-050 | In distribution | |
| 5820-110-50C | In distribution | |
| 8470-107-030D | In distribution | |
| 5820-12-020 | In distribution | |
| 5820-107-430 | In distribution | |
| 1900-015-025 | In distribution | |
| 5540-009-320 | In distribution | |
| 5820-10-145 | In distribution | |
| 5540-012-320 | In distribution | |
| 2296-100-230 | In distribution | |
| 5130-080-030s3 | In distribution | |
| 5130-30-75 | In distribution | |
| 5300-20-509 | In distribution | |
| 5820-107-40 | In distribution | |
| 5540-012-040 | In distribution | |
| 5120-130-250 | In distribution | |
| 2296-100-26 | In distribution | |
| 8450-107-025L | In distribution | |
| 5820-25-040 | In distribution | |
| 5820-10-140 | In distribution | |
| 5820-12-320D | In distribution | |
| 2296-100-321 | In distribution | |
| 110135 | In distribution | |
| 5540-011-310 | In distribution | |
| 8450-013-050DX | In distribution | |
| 5820-12-040 | In distribution | |
| 8450-107-030 | In distribution | |
| 5120-66-21 | In distribution | |
| 5820-009-050 | In distribution | |
| 8450-107-030D | In distribution | |
| 5820-13-030 | In distribution | |
| 5820-110-20 | In distribution | |
| 5820-12-330D | In distribution | |
| 5820-10-240 | In distribution | |
| 5820-107-30 | In distribution | |
| 5820-10-130 | In distribution | |
| 5820-12-060 | In distribution | |
| 5820-13-150 | In distribution | |
| 5120-10-40 | In distribution | |
| 5820-13-040 | In distribution | |
| 5820-107-530C | In distribution | |
| 5820-15-030 | In distribution | |
| 8450-009-030 | In distribution |
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 |
| De Soutter Medical | DE Soutter Medical Ltd. | 143 |
| Jota | Jota AG | 112 |
| Conmed | ConMed Corporation | 109 |
| Bur, Round, round shank | Gebr. Brasseler Gmbh & Co. KG | 104 |
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.