Identity
- Trade Name
- Globe Scientific FDA UDI
- Generic Name
- Histological tissue cassette biopsy insert IVD FDA UDI
- Device Name
- Biopsy Pad for Cassettes, Foam, Blue, 30.2mm x 25.4mm x 2mm, 1000/Pack FDA UDI
- Model / Reference
- 190195 FDA UDI
- Description
- Biopsy Pad for Cassettes, Foam, Blue, 30.2mm x 25.4mm x 2mm, 1000/Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840095604475 FDA UDI
- FDA Product Code
- IDZ FDA UDI
- GMDN Term
- Histological tissue cassette biopsy insert IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Histological tissue cassette biopsy insert IVD
Globe Scientific by Globe Scientific, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Histological tissue cassette biopsy insert IVD.
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- Tissue-Tek® Paraform® — Sakura Finetek USA, Inc · Class I
- Tissue-Tek® Paraform® — Sakura Finetek USA, Inc · Class I
- Histo-Tek® — Sakura Finetek USA, Inc · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Globe Scientific, Llc
Sources (1)
- FDA UDI 1834b3b3-9a9d-4d4b-96bb-14b3218c71b6 33 fields · synced May 30, 2026