Identity
- Trade Name
- Procedure Products Syringe FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- 20cc, Palm-Pad Control Syringe, Red Plunger FDA UDI
- Model / Reference
- 5370-R FDA UDI
- Description
- 20cc, Palm-Pad Control Syringe, Red Plunger FDA UDI
Identifiers
- Primary DI / UDI-DI
- B1605370R1 FDA UDI
- 510(k) Number
- K884985 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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: General-purpose syringe, single-use
Procedure Products Syringe by Procedure Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose syringe, single-use.
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- SURGYCO — Surgyco LLC · Class I
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Cleared under the same submission
K884985 also covers:
- Procedure Products Syringe — PROCEDURE PRODUCTS, INC.
- Procedure Products Syringe — PROCEDURE PRODUCTS, INC.
- Procedure Products Syringe — PROCEDURE PRODUCTS, INC.
- Procedure Products Syringes — PROCEDURE PRODUCTS, INC.
- Procedure Products Syringes — PROCEDURE PRODUCTS, INC.
- Procedure Products Syringes — PROCEDURE PRODUCTS, INC.
- Procedure Products Syringes — PROCEDURE PRODUCTS, INC.
- Procedure Products Syringes — PROCEDURE PRODUCTS, INC.
- Procedure Products Syringes — 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 |
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Manufacturer
- Manufacturer
- Procedure Products, Inc.
Sources (1)
- FDA UDI ffc98ca7-995a-4d0b-bcc5-2b2d697fc747 34 fields · synced Jun 8, 2026