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Glide
EUDAMEDFDA UDIClass I (EU MDR)
Ref 91000-GL-CModel Glide - For Motion Control Standard Wrist or Ottobock 10S17 Wrist Configuration
Identity
- Trade Name
- Glide EUDAMEDFDA UDI
- Generic Name
- Myoelectric hand prosthesis FDA UDI
- Device Name
- Glide EUDAMEDGlide - For Ottobock Axon-Bus System(AxonArm Ergo, Michelangelo hand, AxonHook, and/or AxonRotation) configurations FDA UDI
- Model / Reference
- Glide - For Motion Control Standard Wrist or Ottobock 10S17 Wrist Configuration EUDAMED91000-GL-C EUDAMEDFDA UDI
- Description
- Glide - For Ottobock Axon-Bus System(AxonArm Ergo, Michelangelo hand, AxonHook, and/or AxonRotation) configurations FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850004850633 EUDAMEDFDA UDI
- Basic UDI-DI
- 850004850GLIDE4C EUDAMED
- 510(k) Number
- K240884 FDA UDI
- FDA Product Code
- GXY FDA UDIIQZ FDA UDI
- EMDN Code
- Y240918 CONTROL SENSORS EUDAMED
- GMDN Term
- Myoelectric hand prosthesis FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI890.3420 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
MR Unsafe FDA UDI
Glide by Infinite Biomedical Technologies LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 850004850GLIDE4C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Infinite Biomedical Technologies LLC
- EUDAMED SRN
- US-MF-000007619
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED d5edc938-7a57-4576-87e1-4a7fd2d9906d 61 fields · synced May 30, 2026
- FDA UDI a1b1da6d-e9a8-495a-947c-d1c09b28994b 34 fields · synced May 30, 2026