Identity
- Trade Name
- SURGUARD3 FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- SURGUARD3 Safety Hypodermic Needle FDA UDI
- Model / Reference
- SG3+2338 FDA UDI
- Description
- SURGUARD3 Safety Hypodermic Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14806017509672 FDA UDI
- 510(k) Number
- K113422 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
Dimensions & Sizes
- Size
- Needle Gauge — 23 Gauge FDA UDILength — 1.5 Inch FDA UDI
Category: Hypodermic needle, single-use
Surguard3 by Terumo (Philippines) Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
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Cleared under the same submission
K113422 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- SURGUARD3 — Terumo (Philippines) Corporation
- SURGUARD3 — Terumo (Philippines) Corporation
- SURGUARD3 — Terumo (Philippines) Corporation
- SURGUARD3 — Terumo (Philippines) Corporation
- SURGUARD3 — Terumo (Philippines) Corporation
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
- Terumo (Philippines) Corporation
Sources (1)
- FDA UDI 80bd97ac-17a3-423c-92a9-6e97f246f7cb 37 fields · synced Jun 8, 2026