Identity
- Trade Name
- Disposable Blade Assembly FDA UDI
- Generic Name
- Hand ligament surgical release instrument FDA UDI
- Device Name
- Endoscopic Carpal Tunnel Release Disposable Blade Assembly FDA UDI
- Model / Reference
- CTR-455 FDA UDI
- Description
- Endoscopic Carpal Tunnel Release Disposable Blade Assembly FDA UDI
Identifiers
- Catalog Number
- CTR-455 FDA UDI
- Primary DI / UDI-DI
- 10861994000288 FDA UDI
- 510(k) Number
- K222490 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Hand ligament surgical release instrument FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand ligament surgical release instrument
Disposable Blade Assembly by Hand Biomechanics Lab, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand ligament surgical release instrument.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hand Biomechanics Lab, Inc.
Sources (1)
- FDA UDI d0d2f3a3-5560-49ee-aab8-cf3fcb166368 36 fields · synced May 30, 2026