Identity
- Trade Name
- Lapra-TY EUDAMEDFDA UDI
- Generic Name
- Open-surgery ligation clip applier FDA UDI
- Device Name
- Lapra-TY Suture Clip Applier 33cm Shaft Length -11mm Diameter FDA UDI
- Model / Reference
- KA200 EUDAMEDFDA UDI
- Description
- Lapra-TY Suture Clip Applier 33cm Shaft Length -11mm Diameter FDA UDI
Identifiers
- Catalog Number
- KA200 FDA UDI
- Primary DI / UDI-DI
- D-USMF000013107000040M7 EUDAMED20705036012648 FDA UDI
- Basic UDI-DI
- B-USMF000013107000040M7 EUDAMED
- FDA Product Code
- GDO FDA UDI
- EMDN Code
- L020801 MULTIPLE CLIPS APPLICATORS FOR OPEN SURGERY, REUSABLE EUDAMED
- GMDN Term
- Open-surgery ligation clip applier FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery ligation clip applier
Lapra-TY by Ethicon Endo-Surgery, LLC — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000013107000040M7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED ac831a69-6cd1-434c-bf12-d216901e2c7f 61 fields · synced Jul 31, 2026
- FDA UDI ae099f4b-baee-4989-aaa2-9423ee2b6379 35 fields · synced May 29, 2026