Identity
- Trade Name
- SURGUARD3 FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe FDA UDI
- Device Name
- SURGUARD3 Hypodermic Syringe with Safety Needle FDA UDI
- Model / Reference
- SG3-03L2038 FDA UDI
- Description
- SURGUARD3 Hypodermic Syringe with Safety Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 34806017508464 FDA UDI
- 510(k) Number
- K113422 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe 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
Dimensions & Sizes
- Size
- Length — 1.5 Inch FDA UDITotal Volume — 3 Milliliter FDA UDINeedle Gauge — 20 Gauge FDA UDI
Category: Metered-delivery hypodermic syringe
Surguard3 by Terumo (Philippines) Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metered-delivery hypodermic syringe.
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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 b66a4850-2b68-4d19-a05c-71d2cfb89e20 37 fields · synced May 30, 2026