Identity
- Trade Name
- Director Sterile Disposable Needle Guide FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Model / Reference
- 4023 FDA UDI
Identifiers
- Catalog Number
- 4023 FDA UDI
- Primary DI / UDI-DI
- 00841912101078 FDA UDI
- 510(k) Number
- K973958 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
Yes
FDA UDI
Category: Needle guide, single-use
Director Sterile Disposable Needle Guide by Protek Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, single-use.
- Sterile transrectal needle guide with sheath — Exact Imaging · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- Verza Guidance System Master Carton — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Gangi-SoftGuard Coaxial Needle — Apriomed AB · Class II
Cleared under the same submission
K973958 also covers:
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director XT Multi Gauge Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- ProV-Access Non-Sterile Vascular Access Needle Guides — PROTEK MEDICAL 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
- Protek Medical Products, Inc.
Sources (1)
- FDA UDI dfb2c028-c812-48eb-b591-735736b51a6c 34 fields · synced May 30, 2026