Identity
- Trade Name
- One third tubular locking plate, 97mm/8 holes FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- One third tubular locking plate, 97mm/8 holes FDA UDI
- Model / Reference
- 100-0700-008 FDA UDI
- Description
- One third tubular locking plate, 97mm/8 holes FDA UDI
Identifiers
- Catalog Number
- 100-0700-008 FDA UDI
- Primary DI / UDI-DI
- EMAH10007000080 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 97.0 Millimeter FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile
One third tubular locking plate, 97mm/8 holes by mahe medical gmbh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
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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
- mahe medical gmbh
Sources (1)
- FDA UDI 71f431c4-63b1-4667-b2c2-438b7c8356ee 36 fields · synced Jun 8, 2026