Reloading Unit for Linear Cutter Stapler
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- PANTHER Reloading Unit for Linear Cutter Stapler EUDAMEDPANTHER Reloading Unit for Cutter Stapler EUDAMEDReloading Unit for Linear Cutter Stapler FDA UDI
- Generic Name
- Open-surgery manual linear cutting stapler, single-use FDA UDI
- Device Name
- Reloading Unit for Linear Cutter Stapler EUDAMEDReloading Unit for Cutter Stapler EUDAMED
- Model / Reference
- SADA-60D EUDAMEDSADA-100D EUDAMEDSADC-100N EUDAMEDSADC-60N EUDAMEDSADC-75D EUDAMEDSADC-55N EUDAMEDSADC-100T EUDAMEDCAZB-90T EUDAMEDCAZB-60D EUDAMEDCAZB-40N EUDAMEDSADC-55T EUDAMEDCAZB-60T EUDAMEDSADC-75T EUDAMEDSADC-110D EUDAMEDCAZB-40D EUDAMEDSADC-60T EUDAMEDCAZB-90N EUDAMEDCAZB-60N EUDAMEDSADC-100D EUDAMEDSADA-60N EUDAMEDSADB-60D (4.8mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06939282469097 EUDAMED06939282469134 EUDAMED06939282414127 EUDAMED06939282414097 EUDAMED06939282414288 EUDAMED06939282414080 EUDAMED06939282413946 EUDAMED06939282478150 EUDAMED06939282478105 EUDAMED06939282478075 EUDAMED06939282412642 EUDAMED06939282478143 EUDAMED06939282413922 EUDAMED06939282414318 EUDAMED06939282478082 EUDAMED06939282412659 EUDAMED06939282478112 EUDAMED06939282478099 EUDAMED06939282414301 EUDAMED06939282469080 EUDAMED06939282469059 FDA UDI
- Basic UDI-DI
- B-06939282469097 EUDAMEDB-06939282469134 EUDAMEDB-06939282414127 EUDAMEDB-06939282414097 EUDAMEDB-06939282414288 EUDAMEDB-06939282414080 EUDAMEDB-06939282413946 EUDAMEDB-06939282478150 EUDAMEDB-06939282478105 EUDAMEDB-06939282478075 EUDAMEDB-06939282412642 EUDAMEDB-06939282478143 EUDAMEDB-06939282413922 EUDAMEDB-06939282414318 EUDAMEDB-06939282478082 EUDAMEDB-06939282412659 EUDAMEDB-06939282478112 EUDAMEDB-06939282478099 EUDAMEDB-06939282414301 EUDAMEDB-06939282469080 EUDAMED
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMEDH020299 STAPLERS FOR OPEN SURGERY - OTHER EUDAMED
- GMDN Term
- Open-surgery manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIb 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
Reloading Unit for 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
- Disposable Circumcision Staplers — Sinolinks Medical Innovation, Inc. · Class IIa
- 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 (21)
- FDA UDI 6b21f15e-30ad-45ab-8825-734f3e59f53e 32 fields · synced Aug 3, 2026
- EUDAMED b7571fea-8441-48d4-a2cc-de1034209625 61 fields · synced Jul 8, 2026
- EUDAMED f0377942-a663-4ffc-8c69-7e46775ac900 61 fields · synced Jul 9, 2026
- EUDAMED b940d8e8-1764-4317-aa59-8cfe9cbfd557 61 fields · synced Jul 9, 2026
- EUDAMED 29730f04-aeba-4071-90d6-1a06813caa92 61 fields · synced Jul 10, 2026
- EUDAMED c120f0bf-ed4c-4945-a514-a85277804b7e 61 fields · synced Jul 10, 2026
- EUDAMED 7dc559b5-2c94-4550-8215-48e9ac53106d 61 fields · synced Jul 11, 2026
- EUDAMED 30ef3028-6be2-494e-a59c-81982177e585 61 fields · synced Jul 11, 2026
- EUDAMED 44bf604e-2257-4a2e-b8c2-1ed62c1151fc 61 fields · synced Jul 11, 2026
- EUDAMED 75e02202-21d6-4437-bb84-5488ade7dc60 61 fields · synced Jul 12, 2026
- EUDAMED 8d1796bc-ae87-4511-9351-85992337f31e 61 fields · synced Jul 12, 2026
- EUDAMED 5306c53c-e9d5-4690-ab7c-abea21a7308e 61 fields · synced Jul 13, 2026
- EUDAMED ee92baa5-b70e-4827-995a-39135db42fdc 61 fields · synced Jul 14, 2026
- EUDAMED 3da681ff-6aea-4f91-bdc3-1d51593beb28 61 fields · synced Jul 24, 2026
- EUDAMED 889819b9-2c47-413b-8888-cc15f676c9b0 61 fields · synced Jul 25, 2026
- EUDAMED 0084f665-37a5-49f5-8802-faa0c60ce688 61 fields · synced Jul 26, 2026
- EUDAMED 63c9b3ca-deba-4f76-9c09-6492eb3f80ef 61 fields · synced Jul 27, 2026
- EUDAMED efbc75f0-5d1d-4424-b16c-b7aa2e172fb4 61 fields · synced Jul 30, 2026
- EUDAMED 402c18fd-d0bb-4fd3-8c6c-bf2fb9bf4472 61 fields · synced Aug 1, 2026
- EUDAMED c125ad4f-0bee-4f20-9619-9db085b19772 61 fields · synced Aug 2, 2026
- EUDAMED 7e3a4497-a194-4350-bb4b-c79ba38c718b 61 fields · synced Aug 3, 2026