Identity
- Trade Name
- Klein Surgical FDA UDI
- Generic Name
- Open-surgery ligation clip applier FDA UDI
- Device Name
- Klein Bulldog Applier 10mm FDA UDI
- Model / Reference
- 300-400-775 FDA UDI
- Description
- Klein Bulldog Applier 10mm FDA UDI
Identifiers
- Catalog Number
- 300-400-775 FDA UDI
- Primary DI / UDI-DI
- 10850048763309 FDA UDI
- 510(k) Number
- K930496 FDA UDI
- FDA Product Code
- GCI FDA UDI
- GMDN Term
- Open-surgery ligation clip applier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 345 Millimeter FDA UDICircumference — 10 Millimeter FDA UDI
Category: Open-surgery ligation clip applier
Klein Surgical by Klein Surgical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery ligation clip applier.
- WECK — TELEFLEX INCORPORATED · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- S.C.A — SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- WECK — TELEFLEX INCORPORATED · Class I
- WECK — TELEFLEX INCORPORATED · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- Vitalitec Clip Appliers — VITALITEC INTERNATIONAL, INC. · Class I
- WECK — TELEFLEX INCORPORATED · Class I
Cleared under the same submission
K930496 also covers:
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
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
- Klein Surgical Systems, Inc.
Sources (1)
- FDA UDI 230c33a4-9591-4d74-9604-09f36b83f34a 37 fields · synced May 30, 2026