Devon
Needle Counter, 2 Light Handle Covers, Cautery Tip Polisher, Skin Marker, Flexible Ruler, 9 Labels, Suture Bag
105manufacturers in China registered for this device type
43catalogue numbers in this listing
9recalls on this code
Who Else Makes It
Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FSM |
| Device type | Tray, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-10-17 |
| Record revised | 2025-12-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 8, box of 12, case of 4, box of 6, box of 8, box of 21 |
| Sizes | Width 3.75 to 16 in; height 1 to 10 in; length 9 in; depth 1 in |
| Distribution end date | 2026-03-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2040MFLDNS | 200 | In distribution | |
| 1515FLTNS | 200 | In distribution | |
| 2020M2 | In distribution | ||
| 31142931 | 6 | In distribution | |
| 4070FAL | In distribution | ||
| 1020MFLDNS | 200 | In distribution | |
| 3060MFL | In distribution | ||
| 2040FALNS | 200 | In distribution | |
| 1020FALNS | 200 | In distribution | |
| 31141792 | In distribution | ||
| 31141701 | In distribution | ||
| 31141750 | In distribution | ||
| 100M2FLDNS | 100 | In distribution | |
| 2020M2NS | 200 | In distribution | |
| 3030M2L | In distribution | ||
| 1020FAL | In distribution | ||
| 1020MFL | In distribution | ||
| 31159539 | Width 3.75 in | 300 | In distribution |
| 2040MFLNS | 200 | In distribution | |
| 1020MFLD | In distribution | ||
| 31141818 | In distribution | ||
| 31141800 | In distribution | ||
| 4070MFLDNS | 100 | In distribution | |
| 6060M2LNS | 200 | In distribution | |
| 31140588 | Height 10 in | 3 | In distribution |
| 1010MTNS | 200 | In distribution | |
| 1010MT | In distribution | ||
| 1020MFLNS | 200 | In distribution | |
| 31141743 | In distribution | ||
| 100M2FLD | In distribution | ||
| 4070FALNS | 100 | In distribution | |
| 6060M2L | In distribution | ||
| 3060MFLNS | 200 | In distribution | |
| 3030FLNS | 200 | In distribution | |
| 31159513 | 100 | In distribution | |
| 3030M2LD | In distribution | ||
| 4070MFLD | In distribution | ||
| 2040MFLD | In distribution | ||
| 2040MFL | In distribution | ||
| 50000148 | Withdrawn | ||
| 31141784 | Withdrawn | ||
| 31140398 | Depth 1 in | Withdrawn | |
| 31151106 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IMS | HU-Friedy MFG Co., LLC | 2,710 |
| Tray, Surgical, Instrument | Synthes Gmbh | 1,052 |
| Tray, Surgical, Instrument | Medtronic Sofamor Danek, Inc. | 1,012 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 666 |
| Aptus | Medartis Inc. | 588 |
| Acumed | Acumed LLC | 566 |
| Aesculap | Aesculap AG | 532 |
| Sklar | Sklar Corporation | 465 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 438 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 429 |
| Level ONE | KLS-Martin L.P. | 341 |
| Bahadir USA | Bahadir USA LLC | 300 |
Showing 12 of 3,212. All products under Tray, Surgical, Instrument
Recalls
9 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-12-18 | Class II | Package design/selection | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Cat. No. 4FS30SSA: 7488; Cat. No. 4FS31SSA: 48; Cat. No. 4MM | 2016-08-01 |
| 2012-12-18 | Class II | Package design/selection | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736 | 2016-08-01 |
| 2012-12-18 | Class II | Package design/selection | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Cat. No. 4FA70SSA: 1,248; Cat. No. 4FM70SSA: 43,920 | 2016-08-01 |
| 2012-12-18 | Class II | Package design/selection | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Cat. No. 3FA70SSA: 23,808; Cat. No. 3FM70SSA: 54,912 | 2016-08-01 |
| 2012-12-18 | Class II | Package design/selection | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Cat. No. 3FS60SSA: 7,560; Cat. No. 3FS61SSA: 14,184; Cat. No | 2016-08-01 |
| 2012-12-18 | Class II | Package design/selection | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Cat. No. 4FA40SSA: 96; Cat. No. 4FM40SSA: 32,592 | 2016-08-01 |
| 2012-12-18 | Class II | Package design/selection | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Cat. No. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. | 2016-08-01 |
| 2012-12-18 | Class II | Package design/selection | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Cat. No. 4FM100SSA: 4,464 | 2016-08-01 |
| 2012-12-18 | Class II | Package design/selection | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | Cat. No. 3FF80SSA: 16224 | 2016-08-01 |
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.