Lac-Mac
Wrapper, 36 x 36, Level 2, merrow edge light blue thread, RFID Tag
38manufacturers in China registered for this device type
27catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (9), Shanghai (5). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Anhui Ares Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 28 |
| Wuhan Zonsen Medical Products Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 24 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang | Jiangsu | Contract manufacturer | 11 |
| Binzhou Dingyue Clothing Company Limited | Binzhou | Shandong | Contract manufacturer | 7 |
Showing 12 of 38. All 38 manufacturers in China registered for Wrap, Sterilization
Record
| Listed by | LAC-MAC Limited, Canada |
|---|---|
| FDA product code | FRG |
| Device type | Wrap, Sterilization |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K102864 |
| Record published | 2021-03-08 |
| Record revised | 2020-07-29 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Length 15 to 81 in; width 15 to 72 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 92E-IN | Length 54 in | In distribution |
| 084E-DE | Length 18 in | In distribution |
| 084E-AX | Length 54 in | In distribution |
| 084W-AX | Length 54 in | In distribution |
| 092E-HE | Length 45 in | In distribution |
| 084E-VC | Length 65 in | In distribution |
| 084E-AF | Length 18 in | In distribution |
| 084E-TK | Length 54 in | In distribution |
| 084E-HL | Length 15 in | In distribution |
| 084E-BA | Length 30 in | In distribution |
| 084W-FM | Width 72 in | In distribution |
| 92E-IT | Length 36 in | In distribution |
| 084E-AG | Length 23 in | In distribution |
| 084E-GA | Length 24 in | In distribution |
| 092E-IY | Length 54 in | In distribution |
| 084E-AS | Length 45 in | In distribution |
| 084E-SP | Length 70 in | In distribution |
| 084E-TB | Length 45 in | In distribution |
| 084E-AN | Length 36 in | In distribution |
| 084E-DL | Length 80 in | In distribution |
| 084W-AS | Length 45 in | In distribution |
| 084W-OV | Length 72 in | In distribution |
| 92E-IU | Length 54 in | In distribution |
| 084B-ON | Width 60 in | In distribution |
| 084E-XA | Length 20 in | In distribution |
| 92E-IF | Length 45 in | In distribution |
| 092E-AN | Length 36 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 824 |
| Cardinal Health | Cardinal Health 200, LLC | 333 |
| Arjo Wiggins Medical, Inc. | Sterimed, Inc. | 286 |
| Halyard | O&M Halyard, Inc. | 191 |
| Primed | Primed Medical Products Inc. | 154 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 148 |
| Vivit Supply | Vivit Supply LLC | 103 |
| Case Medical | Case Medical, Inc. | 103 |
| Gemini | Medline Industries, Inc. | 89 |
| CareGUARD | Care Essentials PTY Ltd | 72 |
| Halyard | Owens & Minor Distribution, Inc. | 70 |
| Wrap, Sterilization | Steris Corporation | 69 |
Showing 12 of 232. All products under Wrap, Sterilization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102864 | 2011-01-14 |
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.