Identity
- Trade Name
- MEDLINE UNITE FDA UDI
- Generic Name
- Cannulated surgical drill guiding pin FDA UDI
- Device Name
- DRILL BIT, DRILLGAUGE SYSTEM, 2.8MM FDA UDI
- Model / Reference
- MPN10128 FDA UDI
- Description
- DRILL BIT, DRILLGAUGE SYSTEM, 2.8MM FDA UDI
Identifiers
- Catalog Number
- MPN10128 FDA UDI
- Primary DI / UDI-DI
- 10888277698406 FDA UDI
- FDA Product Code
- HXX FDA UDI
- GMDN Term
- Cannulated surgical drill guiding pin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Cannulated surgical drill guiding pin
Medline Unite by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cannulated surgical drill guiding pin.
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- Hyper-C — Degen Medical · Class I
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI de0a3f4a-2569-4a97-8bf6-d679aed10aef 35 fields · synced May 30, 2026