Identity
- Trade Name
- SONTEC SUTURE RULER FDA UDI
- Generic Name
- Medical ruler, reusable FDA UDI
- Device Name
- HEARTLINE SONTEC SUTURE RULER FDA UDI
- Model / Reference
- 2800-600 FDA UDI
- Description
- HEARTLINE SONTEC SUTURE RULER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896070127 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Medical ruler, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 14.25 Inch FDA UDI
Category: Medical ruler, reusable
Sontec Suture Ruler by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical ruler, reusable.
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- T2 — Stryker Corp. · Class I
- MediExpand Cervical Expandable VBR System — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- MR PHACO — Crestpoint Management Ltd. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- ACUMED — ACUMED LLC · Class I
- MR PHACO — Crestpoint Management Ltd. · Class I
- Avalign — AVALIGN TECHNOLOGIES, 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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 963ec499-329f-469b-b5c2-2d35c39bba38 35 fields · synced May 30, 2026