Identity
- Trade Name
- Tunneler FDA UDI
- Generic Name
- Vascular graft tunneller FDA UDI
- Device Name
- Tunneler 1.5 Inch Handle Straight Shaft FDA UDI
- Model / Reference
- 2700-101 FDA UDI
- Description
- Tunneler 1.5 Inch Handle Straight Shaft FDA UDI
Identifiers
- Catalog Number
- 2700-101 FDA UDI
- Primary DI / UDI-DI
- 00192896112087 FDA UDI
- 510(k) Number
- K100518 FDA UDI
- FDA Product Code
- DWP FDA UDI
- GMDN Term
- Vascular graft tunneller FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4475 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
Dimensions & Sizes
- Size
- Length — 20 Inch FDA UDI
Category: Vascular graft tunneller
Tunneler by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular graft tunneller.
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Cleared under the same submission
K100518 also covers:
- Adler Instrument Company — Adler, Inc.
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 297325cc-31e8-4ddb-a564-57d48ae32853 37 fields · synced May 30, 2026