Identity
- Trade Name
- Set Inject FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe FDA UDI
- Device Name
- Syringes without Hypodermic needles Luer Lock 3 part EUDAMEDSyringe Luer Lock - Set Inject - 10 ml 3 p FDA UDI
- Model / Reference
- 21IN-1003000002 EUDAMED21IN-1003000008 FDA UDI
- Description
- Syringe Luer Lock - Set Inject - 10 ml 3 p FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08699207510027 EUDAMEDFDA UDI
- Basic UDI-DI
- 8699207STLL3PONVT EUDAMED
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
- GMDN Term
- Metered-delivery hypodermic syringe FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Category: Metered-delivery hypodermic syringe
Set Inject by Set Medikal Sanayi Ve Ticaret Anonim Sirketi — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Metered-delivery hypodermic syringe.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Set Medikal Sanayi Ve Ticaret Anonim Sirketi
Sources (2)
- FDA UDI ed2d7999-ae16-4902-94fa-f23925f8b4ee 35 fields · synced Jul 9, 2026
- EUDAMED 17d33857-4a79-4bd3-b927-6a557d09f48c 61 fields · synced Jul 9, 2026