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Reloading Unit for Linear Stapler
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref (FLSL)H4.8CRef (FLSL)H4.8BRef (FLSL)H3.5CRef (FLSL)H2.5ARef (FLSL)H4.8A
Identity
- Trade Name
- PANTHER Reloading Unit for Linear Stapler EUDAMEDReloading Unit for Linear Stapler FDA UDI
- Generic Name
- Open-surgery manual linear stapler, single-use FDA UDI
- Device Name
- Reloading Unit for Linear Stapler EUDAMED
- Model / Reference
- (FLSL)H4.8B EUDAMEDFDA UDI(FLSL)H2.5A EUDAMEDFDA UDI(FLSL)H4.8C EUDAMEDFDA UDI(FLSL)H4.8A EUDAMEDFDA UDI(FLSL)H3.5C EUDAMEDFDA UDI(FLSL)H4.8E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06939282439199 EUDAMEDFDA UDI06939282439229 EUDAMEDFDA UDI06939282439205 EUDAMEDFDA UDI06939282439182 EUDAMEDFDA UDI06939282439168 EUDAMEDFDA UDI06939282439212 FDA UDI
- Basic UDI-DI
- B-06939282439205 EUDAMEDB-06939282439199 EUDAMEDB-06939282439168 EUDAMEDB-06939282439229 EUDAMEDB-06939282439182 EUDAMED
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H0202010302 SINGLE-PATIENT LINEAR SUTURE CARTDRIGES WITHOUT BLADE FOR OPEN SURGERY EUDAMED
- GMDN Term
- Open-surgery manual linear 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Safe FDA UDI
Category: Open-surgery manual linear stapler, single-use
Reloading Unit for Linear 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 stapler, single-use.
- Single Use Linear Staplers — Victor Medical Instruments Co., Ltd. · Class IIb
- Single Use Linear Staplers — Victor Medical Instruments Co., Ltd. · Class IIb
- ETHICON SECURESTRAP — Ethicon Inc. · Class II
- TA — Covidien LP · Class II
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
- Single Use Reloadable Linear Cutter Stapler and Reloads — Suzhou Lantex Medical Technology Company Limited · Class IIb
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 (11)
- FDA UDI 6d52bf37-f6ad-4e36-acbb-db1910d62b9e 32 fields · synced Aug 4, 2026
- FDA UDI 842ecc69-a19a-475b-96ef-d578949be14c 32 fields · synced May 25, 2026
- FDA UDI aecffb94-9ad9-4e4f-890a-63ed1345d189 32 fields · synced May 27, 2026
- FDA UDI 2573eb03-7315-4ba1-a190-d9d65ab64e37 32 fields · synced May 30, 2026
- FDA UDI 38db9742-fd54-4cc7-acc7-31e416c98e65 32 fields · synced May 30, 2026
- FDA UDI 6ef10f94-284f-4fb4-ade6-38d84a576e74 32 fields · synced May 30, 2026
- EUDAMED 4668e75b-c934-4b58-b17a-0c807bf97491 61 fields · synced Jun 20, 2026
- EUDAMED 24af4a4d-3e72-4107-aa87-25fe7b257196 61 fields · synced Jul 9, 2026
- EUDAMED 07db6114-f4cd-4866-b509-6fa53c19173a 61 fields · synced Jul 24, 2026
- EUDAMED 8003fd0e-7839-4523-b646-59b6d847dc80 61 fields · synced Jul 30, 2026
- EUDAMED 18e35962-3967-4c15-8daa-638b69ed4778 61 fields · synced Aug 4, 2026