Identity
- Trade Name
- Concentrical blade - length 50 mm FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in minimally invasive spine and orthopedic surgery. These blades are designed to be inserted into a surgical incision to create a precise, circular or semi-circular working channel. FDA UDI
- Model / Reference
- MRS-108-050 FDA UDI
- Description
- A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in minimally invasive spine and orthopedic surgery. These blades are designed to be inserted into a surgical incision to create a precise, circular or semi-circular working channel. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810019931574 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical retractor/retraction system blade, reusable
Concentrical blade - length 50 mm by Bradshaw Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retractor/retraction system blade, reusable.
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- Life Instruments — Life Instrument Corporation · Class I
- Medfix — Medfix International, LLC · Class I
- Specula Retractor Set — Koros USA, 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
- Bradshaw Medical Inc.
Sources (1)
- FDA UDI f6022218-d730-470a-82b1-e79b8ea10607 33 fields · synced May 30, 2026