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The Locking Pediatric Osteotomy Plate system
EUDAMEDFDA UDIClass I (EU MDR)
Ref POP-CYE200-ICModel EMPTY LOLLIPOP INFANT/CHILD SCREW CADDY
Identity
- Trade Name
- The Locking Pediatric Osteotomy Plate system EUDAMEDThe Locking Pediatric Osteotomy Plate (LolliPOP) System FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Device Name
- EMPTY LOLLIPOP INFANT/CHILD SCREW CADDY FDA UDI
- Model / Reference
- EMPTY LOLLIPOP INFANT/CHILD SCREW CADDY EUDAMEDPOP-CYE200-IC EUDAMEDFDA UDI
- Description
- EMPTY LOLLIPOP INFANT/CHILD SCREW CADDY FDA UDI
Identifiers
- Catalog Number
- POP-CYE200-IC FDA UDI
- Primary DI / UDI-DI
- 07540194008947 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194POP-EISC4E EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Surgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
The Locking Pediatric Osteotomy Plate system by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Instrument tray, reusable.
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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 | 7540194POP-EISC4E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoPediatrics Canada ULC
- EUDAMED SRN
- CA-MF-000013010
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED bc8f3176-fe4f-486d-96d6-ca1576e4e519 61 fields · synced Jul 22, 2026
- FDA UDI 46554703-656b-476b-ad54-c056dfb36ec1 36 fields · synced May 30, 2026