← Back to catalogue
MI Intercostal Retractor System (IRS) 222 Small Blade Set
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- MI Intercostal Retractor System (IRS) 222 Small Blade Set FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray. FDA UDI
- Model / Reference
- 3.0 FDA UDI
- Description
- The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray. FDA UDI
Identifiers
- Catalog Number
- MI-IRS-SB-P01 FDA UDI
- Primary DI / UDI-DI
- 00858733006086 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, reusable 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
Yes
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
MI Intercostal Retractor System (IRS) 222 Small Blade Set by Biorep Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retractor/retraction system blade, reusable.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C. · Class I
- Medfix — Medfix International, LLC · Class I
- DELACROIX-CHEVALIER — LANDANGER · Class I
- MSI — Modern Surgical Instruments LLC · Class I
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biorep Technologies, Inc.
Sources (1)
- FDA UDI 8b3ba76c-61d1-4713-8556-b90f1083346f 34 fields · synced Jun 1, 2026