Identity
- Trade Name
- Steriking® FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Single use sterilization packaging FDA UDI
- Model / Reference
- LTSS4A FDA UDI
- Description
- Single use sterilization packaging FDA UDI
Identifiers
- Catalog Number
- LTSS4A FDA UDI
- Primary DI / UDI-DI
- 06438263660121 FDA UDI
- 510(k) Number
- K973827 FDA UDI
- FDA Product Code
- KCT 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
Yes
FDA UDI
Category: Sterilization packaging, single-use
Steriking® by Wipak Packaging (changshu) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sterilization packaging, single-use.
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Cleared under the same submission
K973827 also covers:
- Steriking® — WIPAK PACKAGING (CHANGSHU) CO., LTD.
- Steriking® — WIPAK PACKAGING (CHANGSHU) CO., LTD.
- Steriking® — WIPAK PACKAGING (CHANGSHU) CO., LTD.
- Steriking® — WIPAK PACKAGING (CHANGSHU) CO., LTD.
- Steriking® — WIPAK PACKAGING (CHANGSHU) CO., LTD.
- Steriking® — WIPAK PACKAGING (CHANGSHU) CO., LTD.
- Steriking® — WIPAK PACKAGING (CHANGSHU) CO., LTD.
- Steriking® — WIPAK PACKAGING (CHANGSHU) CO., LTD.
- Steriking® — WIPAK PACKAGING (CHANGSHU) CO., LTD.
- Steriking® — WIPAK PACKAGING (CHANGSHU) CO., LTD.
- Steriking® — Wipak Oy
- Steriking® — Wipak Oy
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
- Wipak Packaging (changshu) Co., Ltd.
Sources (1)
- FDA UDI 062a6533-173a-421b-aa69-1adc5606df3f 35 fields · synced May 30, 2026