Tray “Ear Forceps”
150x130x25.5 mm
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Hubei (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| PRO-MED (Wuxi)IMP.& Exp.co., Ltd. | Wuxi | Jiangsu | Exporter | 24 |
Record
| Listed by | Spiggle & Theis Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | MMO |
| Device type | Tray, Surgical, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-29 |
| Record revised | 2023-04-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80-601-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 63 |
| Integra® | Integra LifeSciences Production Corporation | 16 |
| MicroFrance® | Integra Microfrance SAS | 15 |
| Endoscope container with lid | Spiggle & Theis Medizintechnik Gmbh | 9 |
| Ace Medical Company | Ebner Medical LLC | 7 |
| Integra® | Integra Microfrance SAS | 6 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
| Endoscope container with lid, stainless | Spiggle & Theis Medizintechnik Gmbh | 4 |
| ACE Medical | Ebner Medical LLC | 3 |
| Endoscope sterilizing & protecting tray | Spiggle & Theis Medizintechnik Gmbh | 3 |
| Instrument box with cover | Spiggle & Theis Medizintechnik Gmbh | 3 |
| Fentex | Fentex medical GmbH | 2 |
Showing 12 of 62. All products under Tray, Surgical, 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.