Identity
- Trade Name
- BLUEPHASE SLEEVES FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Bluephase G4 Protect. Sleeves Ref. 1x100 FDA UDI
- Model / Reference
- 691666 FDA UDI
- Description
- Bluephase G4 Protect. Sleeves Ref. 1x100 FDA UDI
Identifiers
- Catalog Number
- 691666 FDA UDI
- Primary DI / UDI-DI
- DVIV6916661 FDA UDI
- FDA Product Code
- PEM 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
No
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
Bluephase Sleeves by Ivoclar Vivadent Aktiengesellschaft — 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
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
- Ivoclar Vivadent Aktiengesellschaft
Sources (1)
- FDA UDI b27d9f25-84bb-42ee-8172-a58daa7868ce 34 fields · synced May 30, 2026