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Monkey Rings™ External Fixation System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name
Monkey Rings™ External Fixation System FDA UDI
Generic Name
External orthopaedic fixation system, single-use FDA UDI
Device Name
Half Pin, Self Drilling, Ø4.0mm x 34mm, 120mm SHANK LENGTH, HA COATED (ST134120HA) FDA UDI
Model / Reference
P45-199-4035-S FDA UDI
Description
Half Pin, Self Drilling, Ø4.0mm x 34mm, 120mm SHANK LENGTH, HA COATED (ST134120HA) FDA UDI

Identifiers

Catalog Number
P45-199-4035-S FDA UDI
Primary DI / UDI-DI
00889795117939 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
External orthopaedic fixation system, single-use 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

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 Unsafe FDA UDI

Category: External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paragon 28

Sources (1)

  • FDA UDI 9ba5ab06-30e6-47d8-83fb-853b8d1c956f 34 fields · synced May 30, 2026