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Hi-Fi

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
HI-FI FDA UDI
Generic Name
Polyolefin/fluoropolymer suture, multifilament FDA UDI
Device Name
Hi-Fi Blue Size 2 40" & White/Black Co-Braid Size 2 40" HC-5 Needle ConMed FDA UDI
Model / Reference
IPN001163 FDA UDI
Description
Hi-Fi Blue Size 2 40" & White/Black Co-Braid Size 2 40" HC-5 Needle ConMed FDA UDI

Identifiers

Catalog Number
H6210T FDA UDI
Primary DI / UDI-DI
44026704604126 FDA UDI
FDA Product Code
GAT FDA UDI
GMDN Term
Polyolefin/fluoropolymer suture, multifilament FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI
Sterilization Method
Chlorine Dioxide FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Polyolefin/fluoropolymer suture, multifilament

Hi-Fi by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyolefin/fluoropolymer suture, multifilament.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 6dd74a88-cb83-4a38-bcf9-f8b406d2e653 36 fields · synced May 30, 2026