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Gap Endo-Exo Medullary System
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref GAP-RUL200Model DEPTH GAGE
Identity
- Trade Name
- The GAP Nail Endo-Exo Medullary System EUDAMEDGAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
- Generic Name
- Medical ruler, reusable FDA UDI
- Device Name
- GAP 2.0 LAG DEPTH RULER FDA UDI
- Model / Reference
- GAP-RUL200 EUDAMEDFDA UDIDEPTH GAGE EUDAMED
- Description
- GAP 2.0 LAG DEPTH RULER FDA UDI
Identifiers
- Catalog Number
- GAP-RUL200 FDA UDI
- Primary DI / UDI-DI
- 07540194016553 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194GAP-SDGPH EUDAMED
- FDA Product Code
- HTJ FDA UDI
- EMDN Code
- L0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE EUDAMED
- GMDN Term
- Medical ruler, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4300 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
No
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: Medical ruler, reusable
Gap Endo-Exo Medullary System by Orthopediatrics Canada ULC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI f75b6138-a7ca-4908-a7f1-b818547808e9 35 fields · synced Oct 6, 2026
- EUDAMED db123ca4-1d73-468c-9e3b-f0a84687be54 61 fields · synced Jul 14, 2026