Device Explorer · FDA GUDID · GMDN 35199

Myelography kit

A collection of devices designed for injecting contrast medium into the subarachnoid (intrathecal) space (usually of the lumbar spine) for the purposes of visualizing the spinal canal by radiographic study. It is also referred to as myelogram tray and typicall

US‑registered devices69in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Cardinal Health 200, Llc6594%
Manus Medical, Llc34%
Carefusion 2200, Inc11%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc6594%
Manus Medical, Llc34%
Carefusion 2200, Inc11%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Custom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INCCustom Healthcare Systems Inc.CARDINAL HEALTHN/A

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OIPRadiology-diagnostic kit66
OGJNerve Block Tray11
PWYLumbar puncture tray (adult & pediatric)5
CAZAnesthesia conduction kit1

GMDN & GCC registration

  • GMDN code 35199 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many myelography kit products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Myelography kit", from 3 companies. The largest labeler is Cardinal Health 200, Llc with 94% of records.

Which FDA product codes apply?

OIP (Radiology-diagnostic kit), OGJ (Nerve Block Tray), PWY (Lumbar puncture tray (adult & pediatric)), CAZ (Anesthesia conduction kit)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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