Consulting Wallah › Device Explorer › IVD & laboratory › General tissue specimen container IVD, no additive
Device Explorer · FDA GUDID · GMDN 63838

General tissue specimen container IVD, no additive

A covered receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain

US‑registered devices65in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Simport Scientific Inc.4874%
Richard-Allan Scientific Company1015%
Compai Healthcare (Shenzhen) Co.,Ltd23%
Biopsafe Aps23%
Starplex Scientific Corp.23%
Pretium Canada Packaging Ulc12%

Top labelers

CompanyDevicesShare
Simport Scientific Inc.4874%
Richard-Allan Scientific Company1015%
Compai Healthcare (Shenzhen) Co.,Ltd23%
Biopsafe Aps23%
Starplex Scientific Corp.23%
Pretium Canada Packaging Ulc12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

QuadraViewQudraViewBiopSafe Biopsy ContainerEprediaSpecTainerCoreDishSECURTAINERHistoplex

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

FDA product codes

CodeNameDevices
IDZCassettes, Tissue10
NNIContainer, Specimen, Non-Sterile6
NNKContainer, Specimen Mailer And Storage, Non-Sterile1

GMDN & GCC registration

  • GMDN code 63838 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 3% · 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.

How many general tissue specimen container ivd, no additive products are registered in the US?

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General tissue specimen container IVD, no additive", from 6 companies. The largest labeler is Simport Scientific Inc. with 74% of records.

Which FDA product codes apply?

IDZ (Cassettes, Tissue), NNI (Container, Specimen, Non-Sterile), NNK (Container, Specimen Mailer And Storage, Non-Sterile)

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.

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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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