Identity
- Trade Name
- ShotBlocker EUDAMEDShotBlocker® FDA UDI
- Generic Name
- Injection site desensitizer, tactile, reusable FDA UDI
- Device Name
- ShotBlocker EUDAMEDShotBlocker 100ct FDA UDI
- Model / Reference
- 8100 EUDAMEDFDA UDI
- Description
- ShotBlocker 100ct FDA UDI
Identifiers
- Catalog Number
- 8100 FDA UDI
- Primary DI / UDI-DI
- 00859911004771 EUDAMEDFDA UDI
- Basic UDI-DI
- 859911004ShotBlockerMT EUDAMED
- Unit of Use DI
- 10859911004778 EUDAMED
- FDA Product Code
- LYG FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Injection site desensitizer, tactile, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5660 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
ShotBlocker by Bionix, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 859911004ShotBlockerMT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bionix LLC
- EUDAMED SRN
- US-MF-000020408
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED b128c083-b031-4910-8f79-8d13c16d0957 61 fields · synced Jul 14, 2026
- FDA UDI 3b6804bd-6dd4-498f-b45b-c6f83fae64dc 35 fields · synced May 30, 2026