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Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit
FDA UDIIdentity
- Trade Name
- Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit FDA UDI
- Generic Name
- Appetite-suppression gastric balloon FDA UDI
- Device Name
- The Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit (A-SP3-015) contains 3 extension tubes with their 3-way stopcocks (P-SP-142), and 3 IFUs FDA UDI
- Model / Reference
- A-SP3-015 FDA UDI
- Description
- The Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit (A-SP3-015) contains 3 extension tubes with their 3-way stopcocks (P-SP-142), and 3 IFUs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005178827 FDA UDI
- GMDN Term
- Appetite-suppression gastric balloon FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Appetite-suppression gastric balloon
Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit by Spatz Fgia (israel) Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Appetite-suppression gastric balloon.
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Spatz Fgia (israel) Ltd
Sources (1)
- FDA UDI eece7818-31a1-4249-a7ac-5c7515171de3 33 fields · synced May 30, 2026