Identity
- Trade Name
- ETHICON SECURESTRAP FDA UDI
- Generic Name
- Open-surgery manual linear stapler, single-use FDA UDI
- Device Name
- ETHICON SECURESTRAP ABSORBABLE FIXATION DEVICE FDA UDI
- Model / Reference
- OPSTRAP20 FDA UDI
- Description
- ETHICON SECURESTRAP ABSORBABLE FIXATION DEVICE FDA UDI
Identifiers
- Catalog Number
- OPSTRAP20 FDA UDI
- Primary DI / UDI-DI
- 10705031231054 FDA UDI
- 510(k) Number
- K123114 FDA UDI
- FDA Product Code
- GDW FDA UDI
- GMDN Term
- Open-surgery manual linear stapler, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Open-surgery manual linear stapler, single-use
Ethicon Securestrap by Ethicon Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Linear Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- Linear Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- Linear Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- TA — Covidien LP · Class II
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
Cleared under the same submission
K123114 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Inc.
Sources (1)
- FDA UDI cb4003b9-82d0-427b-8077-4f55c8f25411 37 fields · synced Jun 1, 2026