Identity
- Trade Name
- ShotBlocker FDA UDI
- Generic Name
- Injection site desensitizer, tactile, reusable FDA UDI
- Device Name
- ShotBlocker 1,000 ct FDA UDI
- Model / Reference
- SB-08004 FDA UDI
- Description
- ShotBlocker 1,000 ct FDA UDI
Identifiers
- Catalog Number
- SB-08004 FDA UDI
- Primary DI / UDI-DI
- 00714646000774 FDA UDI
- FDA Product Code
- LYG FDA UDI
- GMDN Term
- Injection site desensitizer, tactile, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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: Injection site desensitizer, tactile, reusable
ShotBlocker by Bionix, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Injection site desensitizer, tactile, reusable.
- ShotBlocker® — Bionix, LLC · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bionix, LLC
Sources (2)
- FDA UDI 8028b7de-cd1c-4479-9221-f17167be6fc4 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026