Identity
- Trade Name
- BLUEPHASE SLEEVES FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Bluephase sleeves (G2) Refill 5x50 FDA UDI
- Model / Reference
- 608554 FDA UDI
- Description
- Bluephase sleeves (G2) Refill 5x50 FDA UDI
Identifiers
- Catalog Number
- 608554 FDA UDI
- Primary DI / UDI-DI
- DVIV6085541 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
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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
- Ivoclar Vivadent Aktiengesellschaft
Sources (1)
- FDA UDI 117aff1b-7fa6-45a9-9f98-03eb21a11f65 34 fields · synced Jun 1, 2026