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Getinge Pack Self-Seal Sterilization Pouch 25cm x 38cm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Getinge Pack Self-Seal Sterilization Pouch 25cm x 38cm FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Model / Reference
- 6005500048 FDA UDI
Identifiers
- Catalog Number
- 6005500048 FDA UDI
- Primary DI / UDI-DI
- 00814434020684 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
- Not 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
Getinge Pack Self-Seal Sterilization Pouch 25cm x 38cm by Steritec Product Mfg. Co., Inc. — Class II — FDA UDI — listed in FDA GUDID
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
- Getinge Pack Self-Seal Sterilization Pouch 14cm x 28cm — STERITEC PRODUCT MFG. CO., INC.
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
- Manufacturer
- Steritec Product Mfg. Co., Inc.
Sources (1)
- FDA UDI 74c91d63-3966-448b-9dcf-6a08d5bea8db 36 fields · synced May 30, 2026