Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Vascular dilator, reusable FDA UDI
- Device Name
- Tubbs mitral valve dilator, working length 180mm, squeeze handle FDA UDI
- Model / Reference
- 44-555 FDA UDI
- Description
- Tubbs mitral valve dilator, working length 180mm, squeeze handle FDA UDI
Identifiers
- Catalog Number
- 44-555 FDA UDI
- Primary DI / UDI-DI
- 00190660031343 FDA UDI
- 510(k) Number
- K100518 FDA UDI
- FDA Product Code
- DWP FDA UDI
- GMDN Term
- Vascular dilator, reusable 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
Moist Heat or Steam Sterilization FDA UDI
Category: Vascular dilator, reusable
Ambler Surgical by Ambler Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular dilator, reusable.
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI b85267b9-ee85-4c41-ade9-dda4d2d00adf 36 fields · synced Jun 6, 2026