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Permaloop

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name
PERMALOOP FDA UDI
Generic Name
Polyolefin/fluoropolymer suture, multifilament FDA UDI
Device Name
PERMALOOP Suture Blue Braided Tape Loop Straight 31mm Taper 1.3mm 20" (51cm) FDA UDI
Model / Reference
280936 FDA UDI
Description
PERMALOOP Suture Blue Braided Tape Loop Straight 31mm Taper 1.3mm 20" (51cm) FDA UDI

Identifiers

Catalog Number
280936 FDA UDI
Primary DI / UDI-DI
20886705032720 FDA UDI
510(k) Number
K220219 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Polyolefin/fluoropolymer suture, multifilament

Permaloop by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyolefin/fluoropolymer suture, multifilament.

Cleared under the same submission

K220219 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medos International Sàrl

Sources (1)

  • FDA UDI 5578a0ec-6f9b-462f-96c5-fb643cbf7b0c 36 fields · synced May 30, 2026