Identity
- Trade Name
- Strauss Surgical FDA UDI
- Generic Name
- Suturing unit, reusable FDA UDI
- Model / Reference
- STS-ART-400-170SP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850024135734 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Suturing unit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Suturing unit, reusable
Strauss Surgical by American Medical Endoscopy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Suturing unit, reusable.
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- Arthrex® — Arthrex, Inc. · Class I
- HAT-TRICK — Smith & Nephew, Inc. · Class I
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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- American Medical Endoscopy
Sources (1)
- FDA UDI 9ed74d79-d0bc-46fc-bdd2-fb1f1838384d 32 fields · synced May 30, 2026