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Neuster
FDA UDIClass II (US FDA UDI)
by Pms Tibbi Cihazlar Teknolojisi Sanayi Ve Ticaret Anonim Sirketi
Identity
- Trade Name
- NEUSTER FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Sterilization Pouch made of DuPont™ Tyvek® 05 cm x 09 cm FDA UDI
- Model / Reference
- TP 0509 FDA UDI
- Description
- Sterilization Pouch made of DuPont™ Tyvek® 05 cm x 09 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810105211884 FDA UDI
- 510(k) Number
- K160595 FDA UDI
- FDA Product Code
- FRG FDA UDI
- GMDN Term
- Sterilization packaging, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
Yes
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
Category: Sterilization packaging, single-use
Neuster by Pms Tibbi Cihazlar Teknolojisi Sanayi Ve Ticaret Anonim Sirketi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sterilization packaging, single-use.
- Dental City — ICP, INC. · Class II
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- VIVIT Supply — Vivit Supply LLC · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Arjo Wiggins Medical, Inc. — Sterimed, Inc. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
Cleared under the same submission
K160595 also covers:
- Getinge Pack Tyvek Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Roll — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Roll — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Roll — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Tyvek Roll — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
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 II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI dbec5bdd-31c2-479a-8d3a-1f7fc146db57 36 fields · synced Jun 8, 2026