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Neomis

FDA UDI

Class I (US FDA UDI)

by In2bones

Identity

Trade Name
NEOMIS FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
NEOMIS 2 SINGLE USE INSTRUMENTS SET FDA UDI
Model / Reference
G02 20011 FDA UDI
Description
NEOMIS 2 SINGLE USE INSTRUMENTS SET FDA UDI

Identifiers

Catalog Number
G02 20011 FDA UDI
Primary DI / UDI-DI
03760225715116 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

Neomis by In2bones — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
In2bones

Sources (1)

  • FDA UDI d6e2e65a-704a-42e1-a432-f1aa6d05770b 35 fields · synced Jun 8, 2026