Orthomed
CCR Radiolucent 4-TEETH Blade Medial/Lateral Green CCR Radiolucent 4-TEETH Blade Medial/Lateral Green
3manufacturers in China registered for this device type
205catalogue 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 | Ortho-MED, Inc., United States |
|---|---|
| FDA product code | FGN |
| Device type | Retractor, Non-Self-Retaining |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2026-06-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OM 55-0468 | In distribution | |
| OM NL9702-044 | In distribution | |
| OM 46-0823 | In distribution | |
| OM NL9702-031 | In distribution | |
| OM 96-0232 | In distribution | |
| OM 46-0832 | In distribution | |
| OM 55-0475 | In distribution | |
| OM 55-0447 | In distribution | |
| OM 52-0707L | In distribution | |
| OM 55-0467 | In distribution | |
| OM 46-0860 | In distribution | |
| OM 55-0485 | In distribution | |
| OM NL9702-025 | In distribution | |
| OM 86-0108 | In distribution | |
| OM NL9702-010 | In distribution | |
| OM 55-0458 | In distribution | |
| OM NL9702-043 | In distribution | |
| OM 96-0233 | In distribution | |
| OM 55-0472 | In distribution | |
| OM 52-0709LR | In distribution | |
| OM 96-0216 | In distribution | |
| OM 55-0482 | In distribution | |
| OM 52-0708L | In distribution | |
| OM NL9702-020 | In distribution | |
| OM 46-0880 | In distribution | |
| OM 96-0245 | In distribution | |
| OM 52-0705S | In distribution | |
| OM MA 110-723 | In distribution | |
| OM NL9702-014 | In distribution | |
| OM 46-0840 | In distribution | |
| OM 48-0184 | In distribution | |
| OM NL9702-042 | In distribution | |
| OM NL9702-033 | In distribution | |
| OM 46-0855 | In distribution | |
| OM 96-0240 | In distribution | |
| OM 96-0206 | In distribution | |
| OM 55-0463 | In distribution | |
| OM 96-0248 | In distribution | |
| OM 96-0230 | In distribution | |
| OM 46-0838S | In distribution | |
| OM 96-0224 | In distribution | |
| OM 46-0908 | In distribution | |
| OM 46-0830 | In distribution | |
| OM 55-0449 | In distribution | |
| OM 46-0909 | In distribution | |
| OM 96-0200 | In distribution | |
| OM 96-0242 | In distribution | |
| OM 96-0247 | In distribution | |
| OM 96-0207 | In distribution | |
| OM 96-0201 | In distribution | |
| OM 96-0221 | In distribution | |
| OM 48-0201 | In distribution | |
| OM 52-0711S | In distribution | |
| OM 55-0461 | In distribution | |
| OM 55-0466 | In distribution | |
| OM 46-0884 | In distribution | |
| OM 46-0870 | In distribution | |
| OM 48-0204 | In distribution | |
| OM 55-0483 | In distribution | |
| OM 55-0452 | In distribution | |
| OM 55-0448 | In distribution | |
| OM 55-0469 | In distribution | |
| OM NL9702-034 | In distribution | |
| OM 52-0708S | In distribution | |
| OM 55-0450 | In distribution | |
| OM NL9702-023 | In distribution | |
| OM 46-0827 | In distribution | |
| OM 96-0210 | In distribution | |
| OM MA 110-721 | In distribution | |
| OM 52-0705SR | In distribution | |
| OM 96-0215 | In distribution | |
| OM 96-0228 | In distribution | |
| OM NL9702-012 | In distribution | |
| OM 52-0704F | In distribution | |
| OM 46-0841 | In distribution | |
| OM 46-0739 | In distribution | |
| OM 96-0214 | In distribution | |
| OM 46-0906 | In distribution | |
| OM 96-0203 | In distribution | |
| OM 46-0735 | In distribution | |
| OM 96-0223 | In distribution | |
| OM 48-0180 | In distribution | |
| OM 46-0842 | In distribution | |
| OM 46-0854 | In distribution | |
| OM 46-0848 | In distribution | |
| OM 96-0222 | In distribution | |
| OM NL9702-036 | In distribution | |
| OM 55-0451 | In distribution | |
| OM 52-0711L | In distribution | |
| OM 96-0252 | In distribution | |
| OM 55-0465 | In distribution | |
| OM 48-0206 | In distribution | |
| OM 46-0927 | In distribution | |
| OM 96-0239 | In distribution | |
| OM 96-0226 | In distribution | |
| OM 46-0910 | In distribution | |
| OM 96-0238 | In distribution | |
| OM NL9702-021 | In distribution | |
| OM 55-0473 | In distribution | |
| OM 52-0703S | In distribution | |
| OM NL9702-026 | In distribution | |
| OM COD 50-4570 | In distribution | |
| OM NL9702-022 | In distribution | |
| OM 52-0709SR | In distribution | |
| OM 96-0209 | In distribution | |
| OM 96-0243 | In distribution | |
| OM 55-0464 | In distribution | |
| OM 96-0241 | In distribution | |
| OM 96-0253 | In distribution | |
| OM MA 110-834 | In distribution | |
| OM 96-0250 | In distribution | |
| OM NL9702-045 | In distribution | |
| OM 55-0454 | In distribution | |
| OM 52-0706L | In distribution | |
| OM 55-0455 | In distribution | |
| OM 48-0198 | In distribution | |
| OM 48-0194 | In distribution | |
| OM 55-0474 | In distribution | |
| OM NL9702-040 | In distribution | |
| OM 96-0202 | In distribution | |
| OM 46-0852 | In distribution | |
| OM 52-0704L | In distribution | |
| OM 86-0109 | In distribution | |
| OM 52-0704S | In distribution | |
| OM 96-0204 | In distribution | |
| OM 52-0706S | In distribution | |
| OM 48-0212 | In distribution | |
| OM 46-0836 | In distribution | |
| OM 55-0457 | In distribution | |
| OM 48-0208 | In distribution | |
| OM 96-0235 | In distribution | |
| OM 55-0484 | In distribution | |
| OM 96-0218 | In distribution | |
| OM NL9702-030 | In distribution | |
| OM MA 110-836 | In distribution | |
| OM 46-0858 | In distribution | |
| OM 47-0881 | In distribution | |
| OM 96-0219 | In distribution | |
| OM 48-0200 | In distribution | |
| OM 48-0214 | In distribution | |
| OM 96-0251 | In distribution | |
| OM MA 110-739 | In distribution | |
| OM 96-0231 | In distribution | |
| OM 96-0246 | In distribution | |
| OM 46-0872 | In distribution | |
| OM 46-0829 | In distribution | |
| OM NL9702-041 | In distribution | |
| OM 55-0453 | In distribution | |
| OM 96-0234 | In distribution | |
| OM 96-0236 | In distribution | |
| OM 96-0205 | In distribution | |
| OM NL9702-024 | In distribution | |
| OM 96-0212 | In distribution | |
| OM 46-0926 | In distribution | |
| OM 55-0487 | In distribution | |
| OM 55-0460 | In distribution | |
| OM 46-0850 | In distribution | |
| OM 55-0476 | In distribution | |
| OM 55-0488 | In distribution | |
| OM 46-0838 | In distribution | |
| OM 48-0192 | In distribution | |
| OM 52-0707S | In distribution | |
| OM 96-0249 | In distribution | |
| OM COD 50-4569 | In distribution | |
| OM 46-0826 | In distribution | |
| OM 46-0875 | In distribution | |
| OM MA 110-837 | In distribution | |
| OM 96-0225 | In distribution | |
| OM 52-0708LR | In distribution | |
| OM 48-0202 | In distribution | |
| OM NL9702-032 | In distribution | |
| OM 96-0213 | In distribution | |
| OM 96-0211 | In distribution | |
| OM 96-0254 | In distribution | |
| OM 46-0874 | In distribution | |
| OM 46-0849 | In distribution | |
| OM 96-0237 | In distribution | |
| OM 55-0486 | In distribution | |
| OM 52-0711SR | In distribution | |
| OM 52-0706LR | In distribution | |
| OM 46-0891 | In distribution | |
| OM COD 50-4571 | In distribution | |
| OM NL9702-011 | In distribution | |
| OM 55-0456 | In distribution | |
| OM COD 50-4568 | In distribution | |
| OM 48-0196 | In distribution | |
| OM 52-0709L | In distribution | |
| OM 55-0471 | In distribution | |
| OM 52-0709S | In distribution | |
| OM NL9702-015 | In distribution | |
| OM 46-0851 | In distribution | |
| OM 48-0210 | In distribution | |
| OM 55-0459 | In distribution | |
| OM 96-0244 | In distribution | |
| OM 46-0907 | In distribution | |
| OM 55-0462 | In distribution | |
| OM NL9702-013 | In distribution | |
| OM 96-0229 | In distribution | |
| OM 52-0705L | In distribution | |
| OM MA 110-737 | In distribution | |
| OM 96-0217 | In distribution | |
| OM 96-0208 | In distribution | |
| OM 52-0707SR | In distribution | |
| OM 96-0220 | In distribution | |
| OM 96-0227 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 408 |
| Omni-Tract® | Integra Lifesciences Corporation | 252 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 47 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 26 |
| V. Mueller | Steris Corporation | 24 |
| Novo Surgical | Novo Surgical, Inc. | 24 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 18 |
| Ambler Surgical | Ambler Surgical, LLC | 16 |
| Tebbetts Suction Wound Retractor | Sontec Instruments, Inc. | 12 |
| Cochran Pediatric Retractor | Sontec Instruments, Inc. | 10 |
| Pilling | Teleflex Medical LLC | 10 |
| Hill-Ferguson Retractor | Sontec Instruments, Inc. | 8 |
Showing 12 of 51. All products under Retractor, Non-Self-Retaining
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.