Identity
- Trade Name
- Aligned Medical Solutions FDA UDI
- Generic Name
- General surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Soft Tissue Pack FDA UDI
- Model / Reference
- AMS8668A FDA UDI
- Description
- Soft Tissue Pack FDA UDI
Identifiers
- Catalog Number
- AMS8668A FDA UDI
- Primary DI / UDI-DI
- B098AMS8668A0 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- General surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: General surgical procedure kit, non-medicated, single-use
At Aligned Medical Solutions, we offer a comprehensive General Surgical Procedure Kit designed to simplify the process of performing open abdominal surgery, general surgical procedures, non-orthopaedic trauma surgeries, minor dermatological surgeries, or cosmetic surgeries. This single-use device is intended for use in a range of clinical specialties and does not contain pharmaceuticals.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aligned Medical Solutions
Sources (1)
- FDA UDI 724f0437-03a0-4dec-ae86-7995842f4487 36 fields · synced Jul 16, 2026