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Gap Endo-Exo Medullary System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref GAP-WAS100Model WASHER
Identity
- Trade Name
- The GAP Nail Endo-Exo Medullary System EUDAMEDGAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- Cortical Screw Washer Ø3.0 / 4.0mm FDA UDI
- Model / Reference
- GAP-WAS100 EUDAMEDFDA UDIWASHER EUDAMED
- Description
- Cortical Screw Washer Ø3.0 / 4.0mm FDA UDI
Identifiers
- Catalog Number
- GAP-WAS100 FDA UDI
- Primary DI / UDI-DI
- 07540194002129 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194GAP-WSHRL EUDAMED
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P9099 IMPLANTABLE PROSTHETIC DEVICES - OTHER EUDAMED
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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: Implantable bone washer
Gap Endo-Exo Medullary System by Orthopediatrics Canada ULC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Implantable bone washer.
- ISOLA — Depuy Spine, Inc. · Class II
- Spiked Gridlock Screw Washer — Trilliant Surgical LLC · Class II
- Monster Screw System — Paragon 28 · Class II
- ALPHALOK Plating System — Vilex, Inc. · Class II
- Monster Screw System — Paragon 28 · Class II
- FLAT WASHER — Biomet Orthopedics, Inc. · Class II
- Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
- LEOS Cannulated Screw System — Tyber Medical · Class II
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI d30f58ca-6835-4998-98ca-f38fb4f8ba69 36 fields · synced Jun 19, 2026
- EUDAMED 3dac80a6-6949-4f1c-8ee8-2fb268d6154f 61 fields · synced Jun 19, 2026