Identity
- Trade Name
- FasTract Modified Sternal Retractor, Deep Blades FDA UDI
- Generic Name
- Sternum spreader FDA UDI
- Device Name
- Sternal Retractor, Modified Deep Blades, Reusable FDA UDI
- Model / Reference
- RTC-1000-C02 FDA UDI
- Description
- Sternal Retractor, Modified Deep Blades, Reusable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899054002401 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Sternum spreader FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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
Category: Sternum spreader
FasTract Modified Sternal Retractor, Deep Blades by Kdl Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sternum spreader.
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- PILLING — TELEFLEX INCORPORATED · Class I
- PILLING — TELEFLEX INCORPORATED · 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
- Kdl Medical, Inc.
Sources (1)
- FDA UDI 55c6eb44-76c3-461c-b33d-430fe80e9f92 34 fields · synced Jun 8, 2026