DeRoyal
Sterile 773185 FOR Advanced Family Surgery
39manufacturers in China registered for this device type
118catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (14), Zhejiang (6), Guangdong (6). 21 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Jiangsu Likang Medical Products Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 17 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Wuhan Huaxin Nonwoven Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 13 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Kunshan Jiehong Nonwoven Product Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 12 |
Showing 12 of 39. All 39 manufacturers in China registered for Drape, Surgical, Antimicrobial
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | KKX |
| Device type | Drape, Surgical, Antimicrobial |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-12 |
| Record revised | 2021-12-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 25, case of 100, case of 20, case of 40, case of 10, case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 63-107 | In distribution | |
| 63-106 | In distribution | |
| 77-100013NS | In distribution | |
| 30-415 | In distribution | |
| 32-082 | In distribution | |
| 99-11553-D | In distribution | |
| 77-103036TNS | In distribution | |
| 70-103 | In distribution | |
| 77-100015T | In distribution | |
| 99-11555-D | In distribution | |
| 30-0501 | In distribution | |
| 32-1839 | In distribution | |
| 99-18277-D | In distribution | |
| 77-104036TNS | In distribution | |
| 99-13076-D | In distribution | |
| 63-103B | In distribution | |
| 99-17829-D | In distribution | |
| 77-104090 | In distribution | |
| 32-947 | In distribution | |
| 32-2178 | In distribution | |
| 63-110 | In distribution | |
| 61-407 | In distribution | |
| QM-9690 | In distribution | |
| 61-401 | In distribution | |
| 77-103018TNS | In distribution | |
| 77-103620TNS | In distribution | |
| 99-13177-D | In distribution | |
| 77-103640T | In distribution | |
| 63-109 | In distribution | |
| 77-103020T | In distribution | |
| 77-103630T | In distribution | |
| 63-206 | In distribution | |
| 63-208 | In distribution | |
| 32-1884 | In distribution | |
| 32-343 | In distribution | |
| 99-6936-D | In distribution | |
| 63-108 | In distribution | |
| 99-4052-D | In distribution | |
| 32-2007 | In distribution | |
| 59-0802NS | In distribution | |
| 70-150 | In distribution | |
| 30-2900 | In distribution | |
| 99-11392-D | In distribution | |
| 63-207 | In distribution | |
| 63-103 | In distribution | |
| 67-103 | In distribution | |
| 32-998 | In distribution | |
| 77-103636TNS | In distribution | |
| 99-0231 | In distribution | |
| 77-104040T | In distribution | |
| 61-403 | In distribution | |
| 30-0401NS | In distribution | |
| 99-10789-D | In distribution | |
| 99-16338-D | In distribution | |
| 99-5250-D | In distribution | |
| 77-103018T | In distribution | |
| 99-8074-D | In distribution | |
| 63-201 | In distribution | |
| 61-406 | In distribution | |
| 67-106 | In distribution | |
| 59-0802 | In distribution | |
| 63-101 | In distribution | |
| 63-100 | In distribution | |
| 99-4047-D | In distribution | |
| 99-5675-D | In distribution | |
| 99-6841-D | In distribution | |
| 59-0806 | In distribution | |
| 99-17985-D | In distribution | |
| 77-103012T | In distribution | |
| 77-103630TNS | In distribution | |
| 99-0230 | In distribution | |
| 77-103654NS | In distribution | |
| 67-001 | In distribution | |
| 25-012 | In distribution | |
| 77-103654 | In distribution | |
| 77-103640TNS | In distribution | |
| 61-402 | In distribution | |
| 77-103036T | In distribution | |
| 77-104060TNS | In distribution | |
| 63-102 | In distribution | |
| 67-101 | In distribution | |
| 99-19456-D | In distribution | |
| 77-103030T | In distribution | |
| 70-104 | In distribution | |
| 77-100025 | In distribution | |
| 32-358 | In distribution | |
| 77-100011 | In distribution | |
| 63-002-400 | In distribution | |
| 99-19307-D | In distribution | |
| 77-103620T | In distribution | |
| 77-104030T | In distribution | |
| 63-001-400 | In distribution | |
| 77-104036T | In distribution | |
| 32-2037 | In distribution | |
| 32-2177 | In distribution | |
| 99-0229 | In distribution | |
| 77-103030TNS | In distribution | |
| 99-7436-D | In distribution | |
| 77-103636T | In distribution | |
| 77-100025NS | In distribution | |
| 32-2043 | In distribution | |
| 63-202 | In distribution | |
| 99-15289-D | In distribution | |
| 99-7197-D | In distribution | |
| 77-104060T | In distribution | |
| 63-203 | In distribution | |
| 99-8066-D | In distribution | |
| 32-1985 | In distribution | |
| 99-6607-D | In distribution | |
| 99-18193-D | In distribution | |
| 77-104030TNS | In distribution | |
| 32-276 | In distribution | |
| QM-50375 | In distribution | |
| 99-6165-D | In distribution | |
| 77-100012 | In distribution | |
| 63-200 | In distribution | |
| 99-18466-D | In distribution | |
| 77-100013 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microtek | Microtek Medical LLC | 994 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 819 |
| Halyard | O&M Halyard, Inc. | 800 |
| Medline | Medline Industries, Inc. | 517 |
| Convertors | Cardinal Health 200, LLC | 392 |
| Medline Industries, Inc. | Medline Industries, Inc. | 274 |
| TIDIShield | Tidi Products, LLC | 187 |
| Cardinal Health | Cardinal Health 200, LLC | 111 |
| Angiosystems Drape | Angiosystems, Inc. | 109 |
| ComPel Surgical Drape | Standard Textile Co., Inc. | 101 |
| Drape, Surgical, Antimicrobial | Welmed, Inc. | 95 |
| Novo Health Services, LLC | Novo Health Services, LLC | 90 |
Showing 12 of 329. All products under Drape, Surgical, Antimicrobial
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K030365 | 2003-04-29 |
| K950565 | 1995-12-13 |
| K921350 | 1992-08-04 |
| K913486 | 1992-02-05 |
| K914369 | 1991-12-02 |
| K910495 | 1991-02-19 |
| K904960 | 1990-12-13 |
| K864388 | 1987-02-20 |
| K861969 | 1986-06-04 |
| K861196 | 1986-04-30 |
| K860326 | 1986-02-21 |
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.