Medline
Critical Response Shears, Black Handle
36manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (11), Jiangsu (8), Guangdong (7). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Zhejiang Aoki Medical Dressing Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen | Jiangsu | Contract manufacturer | 14 |
| Jiangsu Classic NEW-Type Medical Products Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 13 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
Showing 12 of 36. All 36 manufacturers in China registered for Scissors, Medical, Disposable
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | JOK |
| Device type | Scissors, Medical, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6820 |
| Premarket notification | Exempt |
| Record published | 2024-10-31 |
| Record revised | 2022-09-23 (version 2) |
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 |
| Packaging | Case of 4, case of 50, case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CRSHEARSRE | 50 | In distribution | |
| DYND04035 | In distribution | ||
| CRSHEARSBK | 50 | In distribution | |
| DYND04036 | In distribution | ||
| DYND04001 | 50 | In distribution | |
| DYND04035 | 50 | In distribution | |
| DYND04001A | In distribution | ||
| DYND04006 | In distribution | ||
| CRSHEARSPNK | 50 | In distribution | |
| DYND04025 | 50 | In distribution | |
| CRSHEARSABK | 50 | In distribution | |
| CRSHEARSYEL | 50 | In distribution | |
| DYND04027 | 50 | In distribution | |
| CRSHEARSBLU | 50 | In distribution | |
| CRSHEARSOR | 50 | In distribution | |
| CRSHEARSPUR | 50 | In distribution | |
| DYND04056 | In distribution | ||
| DYND04037 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Scissors, Medical, Disposable | Tetra Medical Supply Corp. | 18 |
| Tissue-Tek® Accu-Edge® | Sakura Finetek U.S.A., Inc. | 15 |
| MedSource Shears | Medsource International, LLC | 12 |
| Centurion | Centurion Medical Products Corporation | 11 |
| Scissors, Medical, Disposable | Haritex Corporation | 9 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 4 |
| Endoch | Endoch Inc | 4 |
| DeRoyal | Deroyal Industries, Inc. | 4 |
| Garish Apparels | Garish Apparels | 3 |
| Scissors | DR. Frigz International (PVT) Ltd. | 3 |
| Elite Shears | Medsource International, LLC | 3 |
| Spetzler Disposable Micro Scissors, Bayonet 9-inch, Straight Tips | Katalyst Surgical, LLC | 2 |
Showing 12 of 48. All products under Scissors, Medical, Disposable
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-02-23 | Class II | Process control | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. | 800 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.