Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- General-purpose endoscopic needle, reusable FDA UDI
- Device Name
- Puncture needle with irrigation, 15 gauge, 5.0mm, 35.0cm FDA UDI
- Model / Reference
- Puncture needle with irrigation FDA UDI
- Description
- Puncture needle with irrigation, 15 gauge, 5.0mm, 35.0cm FDA UDI
Identifiers
- Catalog Number
- 57-410 FDA UDI
- Primary DI / UDI-DI
- 00190660121488 FDA UDI
- 510(k) Number
- K040855 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- General-purpose endoscopic needle, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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: General-purpose endoscopic needle, reusable
Ambler Surgical by Ambler Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose endoscopic needle, reusable.
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Cleared under the same submission
K040855 also covers:
- 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
- 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 3c0ee557-cf47-4ff8-8695-f2a23f0ee6b2 36 fields · synced May 30, 2026