Sklar®

Censitrac Ready Sistrunk Diss Sciss STR 5 3/4 Inches

Registry build 21.09.26
83manufacturers in China registered for this device type
1,579catalogue numbers in this listing
1recall

Who Else Makes It

Concentrated in Zhejiang (36), Jiangsu (20), Guangdong (7). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRW
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Taizhou Xinkang Medical Materials Co., Ltd. Taizhou Jiangsu Contract manufacturer 35
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Meifu Medical Technology Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 13
Suzhou Vicon Industrial Co., Ltd. Suzhou Jiangsu Contract manufacturer 13
Zhejiang Tiansong Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 4
Yangjiang City YUE Cheng Industry AND Trade Co., Ltd. Yangjiang Guangdong Contract manufacturer 2
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263

Showing 12 of 83. All 83 manufacturers in China registered for Scissors, General, Surgical

Record

Regulatory record for Sklar®
Listed by Sklar Corporation, United States
FDA product code LRW
Device type Scissors, General, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-07-11
Record revised 2023-10-18 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Sklar®
Catalogue number Size Per pack Status
15-3620 In distribution
47-1047 In distribution
96-5396 50 In distribution
64-1842 In distribution
41-1105 In distribution
47-1030 In distribution
47-1088 In distribution
97-270 In distribution
90-1690 In distribution
96-2251M 25 In distribution
96-2680M 50 In distribution
64-2230C In distribution
22-2742 In distribution
90-1286 In distribution
47-1146 In distribution
21-160 12 In distribution
90-1290 In distribution
55-9080C In distribution
90-1755 In distribution
97-335 In distribution
75-5075 In distribution
95-375 In distribution
22-2550C In distribution
22-2759 In distribution
16-4000 In distribution
15-3410 In distribution
24-2331 In distribution
23-1153 In distribution
16-9015 In distribution
23-1270 In distribution
47-1267 In distribution
21-241 12 In distribution
64-1853C In distribution
16-2005 In distribution
22-2646 In distribution
47-1140C In distribution
15-2445C In distribution
16-9103 In distribution
48-721 In distribution
15-3308 In distribution
55-9190C In distribution
79-2111 In distribution
13-2060C In distribution
40-5481 In distribution
14-2055C In distribution
64-3288 In distribution
98-7973 In distribution
22-1567 In distribution
11-1180C In distribution
61-0006 In distribution
22-1242C In distribution
47-1350 In distribution
98-9405 In distribution
61-0014 In distribution
97-344 In distribution
16-3540 In distribution
11-1260 In distribution
22-1255 In distribution
96-5394 50 In distribution
41-1147 In distribution
16-9125 In distribution
14-2055LFT In distribution
15-2762C In distribution
55-9612 In distribution
98-2115 In distribution
16-3505 In distribution
98-9100 In distribution
24-1965 In distribution
15-3590 In distribution
95-160 In distribution
61-0009 In distribution
23-1175 In distribution
13-1045C In distribution
98-2180 In distribution
90-1292 In distribution
13-1050C In distribution
15-3460 In distribution
15-2307 In distribution
98-7819 In distribution
95-361 In distribution
50-4654 In distribution
15-1555 In distribution
16-3627 In distribution
15-3315 In distribution
14-1155 In distribution
15-3244 In distribution
55-9411 In distribution
22-1450 In distribution
98-2109 In distribution
22-2760C In distribution
11-1180 In distribution
22-1145 In distribution
41-1134 In distribution
11-1090 In distribution
47-1235C In distribution
55-9312 In distribution
16-3621 In distribution
22-2947 In distribution
97-346 In distribution
98-7803 In distribution
97-272 In distribution
23-1182 In distribution
15-3586 In distribution
16-4006 In distribution
15-1567LFT In distribution
90-1690C In distribution
13-2045 In distribution
98-2117 In distribution
41-1136 In distribution
23-1175C In distribution
61-2004 In distribution
95-241 In distribution
22-1135 In distribution
97-1245 In distribution
22-1245C In distribution
95-354 In distribution
47-1245 In distribution
80-1590 In distribution
96-2529M 25 In distribution
90-1180 In distribution
13-2060 In distribution
52-3170 In distribution
47-1440C In distribution
21-272 12 In distribution
21-105RB 12 In distribution
95-109 In distribution
15-2436 In distribution
15-3335 In distribution
23-1180 In distribution
50-4462 In distribution
15-3368 In distribution
98-7817 In distribution
96-2682M 25 In distribution
23-1124 In distribution
64-1851 In distribution
15-3515 In distribution
75-5270 In distribution
22-1655 In distribution
14-1065C In distribution
22-1135C In distribution
95-226 In distribution
15-1567C In distribution
98-7823 In distribution
23-1151 In distribution
16-3533 In distribution
55-9614 In distribution
98-7816 In distribution
64-3142 In distribution
95-232 In distribution
98-7818 In distribution
15-1285 In distribution
50-4562 In distribution
11-1072 In distribution
47-1058C In distribution
47-1084C In distribution
15-3578 In distribution
23-1105 In distribution
98-160 In distribution
61-0005 In distribution
97-241 In distribution
14-1060C In distribution
98-7920 In distribution
55-8512C In distribution
44-146 In distribution
47-1084 In distribution
16-4005 In distribution
16-2010 In distribution
98-9449 In distribution
55-9080 In distribution
13-2050 In distribution
16-9110 In distribution
16-1055 In distribution
22-1354 In distribution
64-1950C In distribution
23-1260 In distribution
15-3509 In distribution
98-1052 In distribution
23-1202 In distribution
40-5484 In distribution
22-1250C In distribution
24-2340 In distribution
24-1962 In distribution
22-2545C In distribution
64-1242 In distribution
15-3426 In distribution
22-1545 In distribution
41-1145 In distribution
14-1055C In distribution
55-9612C In distribution
97-336 In distribution
22-1240C In distribution
98-367 In distribution
64-1342C In distribution
15-3535 In distribution
96-2263M 25 In distribution
15-9301 In distribution
15-2667C In distribution
64-2042 In distribution
98-7898 In distribution
22-1057 In distribution
64-3450 In distribution
98-7814 In distribution
97-276 In distribution
14-2072 In distribution
15-2567LFT In distribution
16-9121 In distribution
16-4009 In distribution
40-5483 In distribution
50-4664 In distribution
15-2655C In distribution
11-1280C In distribution
21-263 12 In distribution
96-1228 25 In distribution
15-3352 In distribution
64-3050 In distribution
64-3272 In distribution
11-1055 In distribution
22-2645 In distribution
16-9004 In distribution
22-1241 In distribution
15-1567 In distribution
23-1150C In distribution
64-3270 In distribution
96-2259 25 In distribution
15-3525 In distribution
61-0011 In distribution
55-8611 In distribution
15-3349 In distribution
16-2205 In distribution
47-1144 In distribution
64-1853 In distribution
16-1620 In distribution
55-8512 In distribution
97-364 In distribution
22-2722 In distribution
98-9419 In distribution
96-5398 50 In distribution
16-1057 In distribution
47-1044 In distribution
23-1106 In distribution
15-3500 In distribution
14-1080 In distribution
24-2360 In distribution
90-1280 In distribution
14-2060 In distribution
22-2825 In distribution
64-3435 In distribution
98-4151 In distribution
95-369 In distribution
47-1060 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Peak Medical Peak Medical Distribution Inc 868
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 808
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 748
Ambler Surgical Ambler Surgical, LLC 720
Millennium Avalign Technologies, Inc. 642
Surtex Surtex Instruments Ltd 576
Integra® Miltex® Integra LifeSciences Production Corporation 558
Assi Accurate Surgical & Scientific Instruments Corp. 524
HNM Medical HNM Stainless, LLC. 523
Integra® Jarit® Integra LifeSciences Production Corporation 495
Aesculap Aesculap AG 488
Boss Instruments Boss Instruments, Ltd. 476

Showing 12 of 796. All products under Scissors, General, Surgical

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Sklar®
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Sklar Corporation UDI-DI 2024-12-03 Class II Under Investigation by firm Reports of various packaging issues that may result in a breach of the sterile barrier. 252865 units
Sklar Corporation UDI-DI 2024-12-03 Class II Under Investigation by firm Reports of various packaging issues that may result in a breach of the sterile barrier. 350 units

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer