Integra® Miltex®
Hatchet, Gold Foil 15L, Off-Angled, Red-Yellow,Tactile Tone™
5manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Shandong (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 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EKH |
| Device type | Carver, Dental Amalgam, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-19 |
| Record revised | 2024-03-25 (version 5) |
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 |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| THH1BK | Withdrawn | |
| THH1 | Withdrawn | |
| TGF13 | Withdrawn | |
| THH1B | Withdrawn | |
| TZCCD | Withdrawn | |
| TZC12 | Withdrawn | |
| TGF15L | Withdrawn | |
| THH15 | Withdrawn | |
| THH1BX-KG | Withdrawn | |
| TGF15L-RY | Withdrawn | |
| TCCD3DD | Withdrawn | |
| TGF13L | Withdrawn | |
| TGF15-RY | Withdrawn | |
| TGF13-RY | Withdrawn | |
| THH13 | Withdrawn | |
| TZC1011 | Withdrawn | |
| TCCD2GG | Withdrawn | |
| TGF14 | Withdrawn | |
| THH1BXGW | Withdrawn | |
| TCHL12GK | Withdrawn | |
| THH15YK | Withdrawn | |
| THH1BX | Withdrawn | |
| THH15-KK | Withdrawn | |
| THH15-GW | Withdrawn | |
| THH1B-KK | Withdrawn | |
| TGF13L-RY | Withdrawn | |
| THH1-GY | Withdrawn | |
| TGF14L-RY | Withdrawn | |
| TGF14-RY | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 284 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 154 |
| American Eagle Instruments | American Eagle Instruments | 72 |
| Zoll-Dental | Zoll-Dental | 43 |
| Power Dental USA | Power Dental U.S.A. Inc. | 39 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 38 |
| Sklar® | Sklar Corporation | 33 |
| Reicodent | Devemed Gmbh | 29 |
| Premier Carvers | Premier Dental Products Co. | 20 |
| J & J Instruments Inc | J & J Instruments, LLC | 20 |
| devemed | Devemed Gmbh | 16 |
| PDT, Inc. | PDT, Inc. | 16 |
Showing 12 of 41. All products under Carver, Dental Amalgam, Operative
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.