Identity
- Trade Name
- PANTHER Cutter Stapler EUDAMEDLinear Cutter Stapler FDA UDI
- Generic Name
- Open-surgery manual linear cutting stapler, single-use FDA UDI
- Device Name
- Cutter Stapler EUDAMED
- Model / Reference
- CAAB-60 EUDAMEDSSAB-80 3.8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06939282478051 EUDAMED06939282468069 FDA UDI
- Basic UDI-DI
- B-06939282478051 EUDAMED
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H020299 STAPLERS FOR OPEN SURGERY - OTHER EUDAMED
- GMDN Term
- Open-surgery manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Open-surgery manual linear cutting stapler, single-use
Linear Cutter Stapler by B. J. ZH. F. Panther Medical Equipment Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Open-surgery manual linear cutting stapler, single-use.
- GIA — Covidien LP · Class II
- ZHY series of disposable auto linear stapler and cartridge — Changzhou Waston Medical Appliance Co., Ltd · Class IIb
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
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- Disposable Linear Cutter Stapler and Reload — Jiangsu Brightness Medical Devices Co.,Ltd. · Class IIb
- Disposable Linear Cutter Stapler and Reload — Jiangsu Brightness Medical Devices Co.,Ltd. · Class IIb
- Cartridge for Disposable Linear Cutter — Changzhou Waston Medical Appliance Co., Ltd · Class IIb
- Disposable Endoscopic Linear Cutter Staplers and Cartridges — ChangZhou 3R Medical Device Technology Co.,Ltd · Class IIb
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- B. J. ZH. F. Panther Medical Equipment Co., Ltd.
Sources (2)
- FDA UDI ffe6bd77-b935-448a-8f97-c815502faf68 32 fields · synced Jul 9, 2026
- EUDAMED aa3bd1e1-693e-45f2-ae00-38d0bbc91e30 61 fields · synced Jul 9, 2026