Identity
- Trade Name
- PECTUS SYSTEM FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Model / Reference
- 01-3925 FDA UDI
Identifiers
- Catalog Number
- 01-3925 FDA UDI
- Primary DI / UDI-DI
- 00841036095673 FDA UDI
- 510(k) Number
- K972420 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Surgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
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: Funnel chest remodelling barSurgical instrument/implant rack
Pectus System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K972420 also covers:
- PECTUS SUPPORT BAR — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
- PECTUS SYSTEM — BIOMET MICROFIXATION, INC
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Microfixation, Inc
Sources (1)
- FDA UDI 1c69488a-84b7-45bf-90bd-8db7e0181eda 35 fields · synced Jun 8, 2026