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Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L FDA UDI
- Model / Reference
- HAF-2LGS FDA UDI
- Description
- Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899054002838 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument assist arm system, manually-adjusted
Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L by Kdl Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument assist arm system, manually-adjusted.
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- Flexarm Surgical Holders and Positioners — FLEXBAR MACHINE CORP. · Class I
- II Ring Retractor — AUTOMATED MEDICAL PRODUCTS CORP. · Class I
- ASSISTO® Arm-System — Geomed Medizin-Technik GmbH & Co. KG · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Kdl Medical, Inc.
Sources (1)
- FDA UDI f8724b7f-cfd3-4640-a470-650851f1d85a 34 fields · synced May 30, 2026