← Back to catalogue
Getinge Pack Self-Seal Sterilization Pouch 14cm x 28cm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Getinge Pack Self-Seal Sterilization Pouch 14cm x 28cm FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Model / Reference
- 6005500045 FDA UDI
Identifiers
- Catalog Number
- 6005500045 FDA UDI
- Primary DI / UDI-DI
- 00814434020653 FDA UDI
- 510(k) Number
- K152669 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
No
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
Getinge Pack Self-Seal Sterilization Pouch 14cm x 28cm by Steritec Product Mfg. Co., Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Sterilization packaging, single-use.
- Dental City — ICP, INC. · Class II
- Essentials by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- 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
K152669 also covers:
- Getinge Pack Self-Seal Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Self-Seal Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Self-Seal Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Self-Seal Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Self-Seal Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Self-Seal Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Self-Seal Pouch — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
- Getinge Pack Self-Seal Pouch — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Steritec Product Mfg. Co., Inc.
Sources (1)
- FDA UDI 5b14ba44-189d-481d-a065-ce9e99593e74 35 fields · synced May 30, 2026