Identity
- Trade Name
- SureLock® FDA UDI
- Generic Name
- Surgical drill guide obturator FDA UDI
- Model / Reference
- CM-9621 FDA UDI
Identifiers
- Catalog Number
- CM-9621 FDA UDI
- Primary DI / UDI-DI
- M543CM9621 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Surgical drill guide obturator FDA UDI
Classification
- Device Class
- Class I 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical drill guide obturator
SureLock® by Cayenne Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide obturator.
- TRIGEN — Smith & Nephew, Inc. · Class I
- DARCO — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- SMALL CANNULATED SCREWS — Smith & Nephew, Inc. · Class II
- JUGGERKNOT FLEX OBTURATOR — Biomet Orthopedics, Inc. · Class II
- NexFix — TORNIER, INC. · Class I
- AM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- NexFix — TORNIER, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cayenne Medical, Inc.
Sources (1)
- FDA UDI 321dd401-77f0-466b-b835-2b51179438fe 33 fields · synced May 30, 2026