← Back to catalogue

Pectus System

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
PECTUS SYSTEM FDA UDI
Generic Name
Funnel chest remodelling bar FDA UDI
Model / Reference
SP-2661 FDA UDI

Identifiers

Catalog Number
SP-2661 FDA UDI
Primary DI / UDI-DI
00841036144265 FDA UDI
510(k) Number
K972420 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Funnel chest remodelling bar FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Pectus System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K972420 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biomet Microfixation, Inc

Sources (1)

  • FDA UDI 6445061c-57d1-4a17-91e1-612b5b124fff 36 fields · synced May 31, 2026