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3M™ Steri-Drape™ Cardiovascular Pack with Ioban™
FDA UDIClass II (US FDA UDI)
by 3m Company
Identity
- Trade Name
- 3M™ Steri-Drape™ Cardiovascular Pack with Ioban™ FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- 3M™ Steri-Drape™ Cardiovascular Pack with Ioban™ 2 Incise Film 6677P, 4/CS FDA UDI
- Model / Reference
- 6677P FDA UDI
- Description
- 3M™ Steri-Drape™ Cardiovascular Pack with Ioban™ 2 Incise Film 6677P, 4/CS FDA UDI
Identifiers
- Catalog Number
- 6677P FDA UDI
- Primary DI / UDI-DI
- 50707387815603 FDA UDI
- 510(k) Number
- K801550 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Patient surgical drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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: Patient surgical drape, single-use
3M™ Steri-Drape™ Cardiovascular Pack with Ioban™ by 3m Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient surgical drape, single-use.
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Cleared under the same submission
K801550 also covers:
- 3M™ Ioban™ — 3M COMPANY
- 3M™ Ioban™ — 3M COMPANY
- 3M™ Ioban™ — 3M COMPANY
- 3M™ Ioban™ — 3M COMPANY
- 3M™ Ioban™ — 3M COMPANY
- 3M™ Ioban™ — 3M COMPANY
- 3M™ Ioban™ — 3M COMPANY
- 3M™ Ioban™ — 3M COMPANY
- 3M™ Steri-Drape™ Cardio/Chest Drape with Ioban™ — 3M COMPANY
- 3M™ Steri-Drape™ Cardiovascular Sheet with Ioban™ — 3M COMPANY
- 3M™ Steri-Drape™ Cesarean-Section Drape with Ioban™ — 3M COMPANY
- 3M™ Steri-Drape™ Craniotomy Drape with Ioban™ — 3M COMPANY
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
- 3m Company
Sources (1)
- FDA UDI 0762aa97-4989-47f2-9980-2a4a8c9964fb 36 fields · synced May 31, 2026