Identity
- Trade Name
- Isoloader Surgical Drape FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Model / Reference
- 1214 FDA UDI
Identifiers
- Catalog Number
- S552133 FDA UDI
- Primary DI / UDI-DI
- 00841912100668 FDA UDI
- 510(k) Number
- K970885 FDA UDI
- FDA Product Code
- MMP FDA UDI
- GMDN Term
- Medical equipment/instrument 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
Yes
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: Medical equipment/instrument drape, single-use
Isoloader Surgical Drape by Protek Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K970885 also covers:
- CT Control Cover — PROTEK MEDICAL PRODUCTS, INC.
- CT Control Cover with Arm Bands — PROTEK MEDICAL PRODUCTS, INC.
- CT Control Cradle Cover — PROTEK MEDICAL PRODUCTS, INC.
- CT Control Rail Cover — PROTEK MEDICAL PRODUCTS, INC.
- CT Cover Procedure Kit — PROTEK MEDICAL PRODUCTS, INC.
- CT Monitor Cover — PROTEK MEDICAL PRODUCTS, INC.
- ClingTouch Sterile Disposable Monitor Cover — PROTEK MEDICAL PRODUCTS, INC.
- ClingTouch Sterile Disposable Monitor Cover — PROTEK MEDICAL PRODUCTS, INC.
- Cord Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Instrument Cover — PROTEK MEDICAL PRODUCTS, INC.
- Instrument Cover with PullUp Insert — PROTEK MEDICAL PRODUCTS, INC.
- Localizer Instrument Cover Kit — PROTEK MEDICAL PRODUCTS, 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
- Protek Medical Products, Inc.
Sources (1)
- FDA UDI 481a291c-b7c0-4363-a41f-6a72fed26890 34 fields · synced May 30, 2026