Battery Pack, Single Use, Pdcmf, Tadiran
Catalogue number PDCMF-BP-001, listed by Pro-Dex Inc, United States, under Motor, Surgical Instrument, Ac-Powered. 7 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (2). 3 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Shenzhen Jinlichang Electronic Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Shenzhen Soga Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Ningbo Advan Electrical Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Pro-Dex Inc, United States |
|---|---|
| FDA product code | GEY |
| Device type | Motor, Surgical Instrument, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-04-01 |
| Record revised | 2024-12-19 (version 2) |
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 |
| Storage | Storage environment temperature -4 to 140 °F; Handling environment humidity 10 to 95 % RH |
| Packaging | Pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PDCMF-BP-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 1,481 |
| HI-Line XS | Aesculap AG | 169 |
| Zaguar | Imedicom Co., Ltd. | 131 |
| Elan 4 | Aesculap AG | 107 |
| Aesculap | Aesculap AG | 72 |
| HI-Line | Aesculap AG | 53 |
| Motor, Surgical Instrument, Ac-Powered | Anspach Effort, The | 37 |
| Zimmer Biomet™ | Zimmer Surgical, Inc. | 29 |
| Motor, Surgical Instrument, Ac-Powered | Synthes Gmbh | 29 |
| HI-Line XXS | Aesculap AG | 22 |
| Motor, Surgical Instrument, Ac-Powered | Smith & Nephew, Inc. | 20 |
| Eccos | Aesculap AG | 11 |
Showing 12 of 149. All products under Motor, Surgical Instrument, Ac-Powered
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-02-15 | Class II | Error in labeling | Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired. | 2000 | |
| 2018-09-25 | Class II | Under Investigation by firm | Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers. | 68 cases of 40 batteries = 2,720 individual batteries | 2022-04-20 |
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.