Identity
- Trade Name
- System Drape FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Sterile polyethylene drape (81.3 x 91.4cm) for use with AccuCARE Positioning and Stabilizing equipment FDA UDI
- Model / Reference
- 610-870, H46222LS FDA UDI
- Description
- Sterile polyethylene drape (81.3 x 91.4cm) for use with AccuCARE Positioning and Stabilizing equipment FDA UDI
Identifiers
- Catalog Number
- 610-870, H46222LS FDA UDI
- Primary DI / UDI-DI
- 10841436104293 FDA UDI
- 510(k) Number
- K970513 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Width — 81.3 Inch FDA UDILength — 91.4 Inch FDA UDI
Category: Medical equipment/instrument drape, single-use
System Drape by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical equipment/instrument drape, single-use.
- Plasdent — PLASDENT CORP. · Class II
- Exact Medical Manufacturing, Inc. — Exact Medical Manufacturing · Class II
- Proteger — DAS Medical International SRL · Class II
- Machine Bag — Dynarex Corp. · Class I
- TIDIShield — TIDI PRODUCTS, LLC · Class II
- MICROTEK — Microtek Medical LLC · Class II
- Plasdent — PLASDENT CORP. · Class II
- Probe Cover — Advance Medical Designs, Inc. · Class II
Cleared under the same submission
K970513 also covers:
- Brachytherapy Kit 3 — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Guide Sheath — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (1)
- FDA UDI c0c29bdb-7b2f-47b8-bf8a-c35ab53d411a 38 fields · synced Jun 8, 2026