Millennium
Fansler Operating Speculum, fiberoptic, slotted tube 2 3/8" long x 1 3/8" dia with custom made autoclavable slotted thermal-plastic obturator and removable fiberoptic light carrier with…
Fansler Operating Speculum, fiberoptic, slotted tube 2 3/8″ long x 1 3/8″ dia with custom made autoclavable slotted thermal-plastic obturator and removable fiberoptic light carrier with universal light cable connector and ACMI base
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
| Well Care (Wuhan) Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | FFQ |
| Device type | Speculum, Rectal |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-05-06 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72-304501F | In distribution | |
| 1-2810 | In distribution | |
| 72-306316F | In distribution | |
| 72-304502E | In distribution | |
| 1-202062 | In distribution | |
| 1-475185 | In distribution | |
| 72-305103F | In distribution | |
| 72-304015F | In distribution | |
| 1-F12103 | In distribution | |
| 72-304502F | In distribution | |
| 72-304503F | In distribution | |
| 72-304011 | In distribution | |
| 72-13475105E | In distribution | |
| 1-F12102 | In distribution | |
| 9-161 | In distribution | |
| 1-2820 | In distribution | |
| 72-303716E | In distribution | |
| 72-304602FSF | In distribution | |
| 1-2880 | In distribution | |
| 1-475105 | In distribution | |
| 1-MB274 | In distribution | |
| 1-2879 | In distribution | |
| 1-6840380 | In distribution | |
| 1-2822 | In distribution | |
| 1-EA800R | In distribution | |
| 1-475130 | In distribution | |
| 72-3064204F | In distribution | |
| 1-6840360 | In distribution | |
| 1-2824 | In distribution | |
| 1-F12104 | In distribution | |
| 1-475110 | In distribution | |
| 1-6840380M | In distribution | |
| 1-63350 | In distribution | |
| 72-304701F | In distribution | |
| 72-303716F | In distribution | |
| 1-5281 | In distribution | |
| 72-303721S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surtex | Surtex Instruments Ltd | 87 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 36 |
| Elmed | Elmed, Inc. | 36 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 35 |
| Hayden Medical | Hayden Medical Inc | 30 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 25 |
| HNM Medical | HNM Stainless, LLC. | 25 |
| Aesculap | Aesculap AG | 25 |
| Sklar® | Sklar Corporation | 17 |
| Pilling | Teleflex Medical LLC | 17 |
| Novo Surgical | Novo Surgical, Inc. | 15 |
| Elmed Incorporated | Elmed, Inc. | 15 |
Showing 12 of 65. All products under Speculum, Rectal
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.