Identity
- Trade Name
- EV ASTRA PIN - EV 1.9mm X 24mm FDA UDI
- Generic Name
- Surgical instrument/implant depth limiter, reusable FDA UDI
- Model / Reference
- 20-0530-19 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D928200530190 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Surgical instrument/implant depth limiter, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument/implant depth limiter, reusable
EV ASTRA PIN - EV 1.9mm X 24mm by W.H. Holden, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/implant depth limiter, reusable.
- Drill Stop — Oco Biomedical · Class I
- Leith Medical Plating System Instruments — Leith Medical LLC · Class II
- MemoFix Super Elastic Nitinol Staple System — Smith & Nephew, Inc. · Class I
- Drill Stop for Pilot Drill — Oco Biomedical · Class I
- MAS PLIF — Nuvasive, Inc. · Class I
- AXIOM® — ETABLISSEMENTS ANTHOGYR · Class I
- AXIOM® — ETABLISSEMENTS ANTHOGYR · Class I
- Distal Radius Plate Trials, 2.3mm Volar, Narrow — FLOWER ORTHOPEDICS CORPORATION · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- W.H. Holden, Inc.
Sources (1)
- FDA UDI 9ac83a02-6001-4afc-9f79-bb8bc7a8317b 32 fields · synced May 30, 2026