Identity
- Trade Name
- SAM ThoraSite® FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- ThoraSite 5-Pack FDA UDI
- Model / Reference
- TS200-5P-EN FDA UDI
- Description
- ThoraSite 5-Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10822045001128 FDA UDI
- FDA Product Code
- GBX FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
No
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
No
FDA UDI
Category: Needle guide, single-use
SAM ThoraSite® by SAM Medical Products — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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- Coaxial needle — Möller Medical GmbH · Class II
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SAM Medical Products
Sources (2)
- FDA UDI 8be158a8-4866-41b4-b3a4-b43a51bd875a 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026