Gemini
Gemini Two Color Bonded Sterilization Wrap, Regular Weight, 24inX24in
38manufacturers in China registered for this device type
89catalogue numbers in this listing
9510(k) clearances naming this product code
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FRG |
| Device type | Wrap, Sterilization |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Record published | 2024-09-26 |
| Record revised | 2026-05-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: NA |
| Packaging | Case of 4, case of 2, case of 3, case of 5, bag of 125, case of 500 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GEM1148TC | 20 | In distribution | |
| GEM1124C | 250 | In distribution | |
| GEM2140 | In distribution | ||
| GEM2154C | 50 | In distribution | |
| GEM1136SC | 50 | In distribution | |
| GEM2118SC | 125 | In distribution | |
| GEM1145C | 50 | In distribution | |
| GEM2154SC | 25 | In distribution | |
| GEM1124SC | 125 | In distribution | |
| GEM2112S | In distribution | ||
| GEM1115S | In distribution | ||
| GEM2140S | In distribution | ||
| GEM1112C | 250 | In distribution | |
| GEM1130TC | 50 | In distribution | |
| GEM1154S | In distribution | ||
| GEM2148S | In distribution | ||
| GEM1118SC | 125 | In distribution | |
| GEM1154TC | 25 | In distribution | |
| GEM1136TC | 50 | In distribution | |
| GEM2148 | In distribution | ||
| GEM2124TC | 125 | In distribution | |
| GEM1112TC | 125 | In distribution | |
| GEM1112SC | 125 | In distribution | |
| GEM1120TC | 125 | In distribution | |
| GEM1145SC | 20 | In distribution | |
| GEM1136C | 100 | In distribution | |
| GEM1115TC | 125 | In distribution | |
| GEM1140 | 50 | In distribution | |
| GEM2124SC | 125 | In distribution | |
| GEM1115SC | 125 | In distribution | |
| GEM1120S | In distribution | ||
| GEM2112SC | 125 | In distribution | |
| GEM5136TC | 36 x 36 in | 24 | In distribution |
| GEM1130C | 100 | In distribution | |
| GEM2120S | In distribution | ||
| GEM1148SC | 20 | In distribution | |
| GEM1140S | 20 | In distribution | |
| GEM1118C | 250 | In distribution | |
| GEM2148TC | 25 | In distribution | |
| GEM1120C | 250 | In distribution | |
| GEM2136SC | 50 | In distribution | |
| GEM1148T | 20 | In distribution | |
| GEM1145 | 50 | In distribution | |
| GEM1145S | In distribution | ||
| GEM1130S | 50 | In distribution | |
| GEM1124TC | 125 | In distribution | |
| GEM2115SC | 125 | In distribution | |
| GEM2115C | 250 | In distribution | |
| GEM1148S | In distribution | ||
| GEM1130 | 100 | In distribution | |
| GEM2118C | 250 | In distribution | |
| GEM2148SC | 25 | In distribution | |
| GEM1148C | 50 | In distribution | |
| GEM1124S | 125 | In distribution | |
| GEM2120SC | 125 | In distribution | |
| GEM2124C | 250 | In distribution | |
| GEM1136 | 100 | In distribution | |
| GEM1140SC | 20 | In distribution | |
| GEM1140C | 50 | In distribution | |
| GEM2130C | 100 | In distribution | |
| GEM1130SC | 50 | In distribution | |
| GEM2136C | 100 | In distribution | |
| GEM2118S | In distribution | ||
| GEM2112C | 250 | In distribution | |
| GEM1115C | 250 | In distribution | |
| GEM1140TC | 20 | In distribution | |
| GEM2136TC | 50 | In distribution | |
| GEM1124 | 250 | In distribution | |
| GEM2130SC | 50 | In distribution | |
| GEM1115 | 250 | In distribution | |
| GEM1124T | 125 | In distribution | |
| GEM2115S | In distribution | ||
| GEM1136S | 50 | In distribution | |
| GEM1118TC | 125 | In distribution | |
| GEM2154TC | 25 | In distribution | |
| GEM1120 | 250 | In distribution | |
| GEM1145T | 20 | In distribution | |
| GEM2118 | 250 | In distribution | |
| GEM2130TC | 50 | In distribution | |
| GEM1120SC | 125 | In distribution | |
| GEM3118C | 200 | In distribution | |
| GEM1154SC | 25 | In distribution | |
| GEM1154C | 50 | In distribution | |
| GEM1145TC | 20 | In distribution | |
| GEM2112 | In distribution | ||
| GEM1112T | 125 | In distribution | |
| GEM2124S | In distribution | ||
| GEM2130S | In distribution | ||
| GEM2120C | 250 | 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 |
| CareGUARD | Care Essentials PTY Ltd | 72 |
| Halyard | Owens & Minor Distribution, Inc. | 70 |
| Wrap, Sterilization | Steris Corporation | 69 |
| Medical Action Industries | Medical Action Industries, Inc. | 58 |
Showing 12 of 232. All products under Wrap, Sterilization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192641 | 2020-01-24 |
| K162993 | 2017-06-23 |
| K152564 | 2016-07-07 |
| K152458 | 2016-06-01 |
| K150698 | 2015-11-20 |
| K143147 | 2015-05-07 |
| K113353 | 2013-01-31 |
| K002968 | 2001-01-23 |
| K841484 | 1984-07-02 |
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.