Grooved Director 130mm
Catalogue number GDR2001, listed by DTR Medical Ltd, United Kingdom, under Probe, Ent. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Record
| Listed by | DTR Medical Ltd, United Kingdom |
|---|---|
| FDA product code | KAK |
| Device type | Probe, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-11 |
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 | Special storage condition: Keep Dry / Keep out of Sunlight |
| Packaging | Pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GDR2001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fentex | Fentex medical GmbH | 52 |
| MicroFrance® | Integra Microfrance SAS | 34 |
| Pilling | Teleflex Medical LLC | 20 |
| HNM Medical | HNM Stainless, LLC. | 19 |
| Ambler Surgical | Ambler Surgical, LLC | 18 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 17 |
| mytaMed | Mytamed, Inc. | 16 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 15 |
| V. Mueller | Steris Corporation | 12 |
| Bowman salivary duct probe | Spiggle & Theis Medizintechnik Gmbh | 11 |
| Millennium | Avalign Technologies, Inc. | 10 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 10 |
Showing 12 of 52. All products under Probe, Ent
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.