Identity
- Trade Name
- HI-LINE XS FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- HI-LINE XS DISP.TWIST DRILL/GB740R D1.2 FDA UDI
- Model / Reference
- GE389SU FDA UDI
- Description
- HI-LINE XS DISP.TWIST DRILL/GB740R D1.2 FDA UDI
Identifiers
- Catalog Number
- GE389SU FDA UDI
- Primary DI / UDI-DI
- 04046963322311 FDA UDI
- FDA Product Code
- GEY FDA UDI
- GMDN Term
- Orthopaedic bur, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bur, single-use
Hi-Line Xs by Aesculap, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (1)
- FDA UDI 8a477a85-858a-4ea6-96be-e29464fd7bdd 35 fields · synced May 31, 2026