Identity
- Trade Name
- Procedure Products Needles FDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- NEEDLE, 2 PART, 10.2cm, 18g, MODIFIED POTTS FDA UDI
- Model / Reference
- 20-1840 FDA UDI
- Description
- NEEDLE, 2 PART, 10.2cm, 18g, MODIFIED POTTS FDA UDI
Identifiers
- Catalog Number
- 20-1840 FDA UDI
- Primary DI / UDI-DI
- B1602018401 FDA UDI
- 510(k) Number
- K810859 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Vascular catheter introduction needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular catheter introduction needle
Procedure Products Needles by Procedure Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter introduction needle.
- Cook — COOK INCORPORATED · Class II
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- Safety Excalibur Introducer System with Punctur-Guard — Bard Access Systems, Inc. · Class II
- Cook — COOK INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- BD Potts-Cournand 18Gx2.05in — BECTON DICKINSON AND COMPANY · Class II
- VASCU-SHEATH® — MEDICAL COMPONENTS INC · Class II
- VASCU-SHEATH® — MEDICAL COMPONENTS INC · Class II
Cleared under the same submission
K810859 also covers:
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needle — PROCEDURE PRODUCTS, INC.
- Procedure Products Needles — PROCEDURE PRODUCTS, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Procedure Products, Inc.
Sources (1)
- FDA UDI 71e5825f-6078-470f-9a5d-5d8f76140c2a 35 fields · synced May 30, 2026