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CT Checker
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref CTCHK57Ref CTCHK50SRef CTCHK57SRef HCTCHK35S
Identity
- Trade Name
- CT Checker EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDIDental guided surgery reference pin FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- CTCHK57S EUDAMEDFDA UDICTCHK50S EUDAMEDFDA UDIHCTCHK35S EUDAMEDFDA UDICTCHK57 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917097842 EUDAMEDFDA UDI08809917097828 EUDAMEDFDA UDI08800209366349 EUDAMEDFDA UDI08809917097859 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDIDental guided surgery reference pin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical drill guide, reusable
CT Checker by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (8)
- FDA UDI ea67831d-d1ca-4eb4-8c11-ce27e0c22a2f 32 fields · synced Jul 28, 2026
- FDA UDI 04cfd74f-403e-4fe1-a2d0-1342e21cb8ad 32 fields · synced May 26, 2026
- FDA UDI a612931f-dab5-46c7-b1de-6c8cebed4b0b 32 fields · synced May 29, 2026
- FDA UDI b3d2e4b9-a0b2-42e4-909e-92a48a901dfb 32 fields · synced May 30, 2026
- EUDAMED c23152db-13fd-4d29-8b33-b4da18fdd7f9 61 fields · synced Jun 20, 2026
- EUDAMED 4dca25b9-c6b6-4b2b-8016-ad3585797559 61 fields · synced Jul 9, 2026
- EUDAMED 477b064d-3efb-4842-a28d-110c4f50474a 61 fields · synced Jul 15, 2026
- EUDAMED 5596a58d-df72-4302-916a-a2c5495be497 61 fields · synced Jul 28, 2026