TCC-EZ®

TOTAL CONTACT CAST SYSTEM - 5 Casting Systems, 5-3" and 5-4" with regular boots

Registry build 21.09.26
81manufacturers in China registered for this device type
24catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (26), Jiangsu (19), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITG
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Anji Hengfeng Sanitary Material Co., Ltd. Anji Zhejiang Contract manufacturer 20
Derma Sciences Nantong Incorporation Development Jiangsu Contract manufacturer 19
Xiantao Rayxin Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 18
Jianerkang Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 18
Kingstar Medical (Xianning) Co., Ltd. Xianning Hubei Contract manufacturer 17
Suzhou Avon Textile Co., Ltd. Suzhou Jiangsu Contract manufacturer 12
Anhui Ivymed Medical Products Co., Ltd. Xuancheng Anhui Contract manufacturer 10
Suzhou Dukangning Medical Products Co., Ltd. Suzhou Jiangsu Contract manufacturer 9

Showing 12 of 81. All 81 manufacturers in China registered for Bandage, Cast

Record

Regulatory record for TCC-EZ®
Listed by Acell, Inc., United States
FDA product code ITG
Device type Bandage, Cast
Device class Class 1
Regulation 21 CFR 890.3025
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-10-23
Record revised 2023-06-08 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number
Storage Storage environment temperature 15 to 30 °C; Storage environment temperature 59 to 86 °F
Distribution end date 2023-12-04

Catalogue Numbers

Catalogue numbers for TCC-EZ®
Catalogue number Size Status
TCC24005 4″ /10cm In distribution
TCC23001 3″ /7.6cm In distribution
TCC21126 4″ W x 3.3125″H In distribution
TCC25051 3″ /7.6cm In distribution
TCC21116 10cm x 3.5cm In distribution
TCC21114 4″ W x 3.3125″H In distribution
TCC24014 4″ /10cm In distribution
TCC23005 3″ /7.6cm In distribution
TCC23051 3″ /7.6cm In distribution
TCC24002 4″ /10cm In distribution
TCC23214 3″ /7.6cm In distribution
TCC24214 4″ /10cm In distribution
TCC23000 3″ /7.6cm In distribution
TCC23002 3″ /7.6cm In distribution
TCC24000 4″ /10cm In distribution
TCC24001 4″ /10cm In distribution
TCC24051 4″ In distribution
TCC21100 10cm x 3.5cm In distribution
TCC21131 4″ W x 3.3125″H In distribution
TCC21124 4″ W x 3.3125″H In distribution
TCC24224 4″ /10cm Withdrawn
TCC24016 4″ /10cm Withdrawn
TCC25050 4″ /10cm Withdrawn
TCC24024 4″ /10cm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
3M™ Scotchcast™ Solventum US LLC 58
Bandage, Cast Tetra Medical Supply Corp. 55
Tex-Care Medical Flynt Amtex, Inc. 45
DeRoyal Deroyal Industries, Inc. 35
McKesson Mckesson Medical-Surgical Inc. 34
PremierPro Prestige Ameritech 31
Emsrun Wuxi Emsrun Technology Co., Ltd. 25
Woodcast Dassiet Oy 15
Curity Cardinal Health 14
Cardinal Health Cardinal Health 200, LLC 13
Senolo Jiangsu Senolo Medical Technology Co., Ltd. 13
Webril Cardinal Health 200, LLC 12

Showing 12 of 66. All products under Bandage, Cast

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