Novo Surgical Inc.
perkins retractor, 3 sharp prongs (7.0 mm long) & solid blades (11.0 x 25.0 mm) w/ spikes, 80.0 mm inside spread, 5" (12.5 cm), 3 prongs on right
3manufacturers in China registered for this device type
42catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), 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 Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | KAL |
| Device type | Retractor, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-12 |
| Record revised | 2024-06-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E3537-24 | In distribution | |
| E7831-63 | In distribution | |
| E3537-25 | In distribution | |
| E7451-15 | In distribution | |
| E7451-10 | In distribution | |
| E7832-46 | In distribution | |
| E8336-32 | In distribution | |
| E3118-19 | In distribution | |
| E7831-33 | In distribution | |
| E7116-29NC | In distribution | |
| E7831-62 | In distribution | |
| E7451-17 | In distribution | |
| E7832-26 | In distribution | |
| E7116-29 | In distribution | |
| E7451-14 | In distribution | |
| E7831-21 | In distribution | |
| E7831-10 | In distribution | |
| E7451-19 | In distribution | |
| G3151-27 | In distribution | |
| E7831-61 | In distribution | |
| E7831-36 | In distribution | |
| E7777-62 | In distribution | |
| E7831-38 | In distribution | |
| E7451-33 | In distribution | |
| E7451-20 | In distribution | |
| E3118-18 | In distribution | |
| E7831-22 | In distribution | |
| E7831-32 | In distribution | |
| E8274-59 | In distribution | |
| E8336-42 | In distribution | |
| E7831-23 | In distribution | |
| E8274-71 | In distribution | |
| E7832-47 | In distribution | |
| E7217-15 | In distribution | |
| NSMO340-1 | In distribution | |
| E7217-21 | In distribution | |
| E7777-61 | In distribution | |
| E8336-31 | In distribution | |
| E7832-36 | In distribution | |
| E8336-26 | In distribution | |
| E8274-31 | In distribution | |
| E3537-31 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 138 |
| Ambler Surgical | Ambler Surgical, LLC | 105 |
| Pilling | Teleflex Medical LLC | 90 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 89 |
| Boss Instruments | Boss Instruments, Ltd. | 61 |
| Avalign | Avalign Technologies, Inc. | 54 |
| Fentex | Fentex medical GmbH | 54 |
| Novo Surgical | Novo Surgical, Inc. | 52 |
| Millennium | Avalign Technologies, Inc. | 47 |
| Aesculap | Aesculap AG | 46 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 43 |
| HNM Medical | HNM Stainless, LLC. | 39 |
Showing 12 of 80. All products under Retractor, 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.