Identity
- Trade Name
- HEARTLINE CRILEWOOD NEEDLE HOLDER FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- HEARTLINE CRILEWOOD NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE CURVED JAW SQUEEZE HANDLE FDA UDI
- Model / Reference
- 2800-010S FDA UDI
- Description
- HEARTLINE CRILEWOOD NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE CURVED JAW SQUEEZE HANDLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896006775 FDA UDI
- 510(k) Number
- K152400 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
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
Dimensions & Sizes
- Size
- Length — 17.8 Centimeter FDA UDI
Category: Suturing needle holder, reusable
Heartline Crilewood Needle Holder by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152400 also covers:
- HEARTLINE BIOPSY GRASPING FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE COLVIN NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
- HEARTLINE COOLEY SCISSORS — SONTEC INSTRUMENTS, INC.
- HEARTLINE FLUSHING ADAPTER — SONTEC INSTRUMENTS, INC.
- HEARTLINE JAMESON TENOTOMY SCISSORS — SONTEC INSTRUMENTS, INC.
- HEARTLINE JAMESON TENOTOMY SCISSORS — SONTEC INSTRUMENTS, INC.
- HEARTLINE KNOT PUSHER FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE KNOT PUSHER FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE MAYO HEGAR NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
- HEARTLINE MINI IMA HOLDING FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE MINI JAW NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
- HEARTLINE RYDER NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI bf745411-7985-4560-8022-948793176d1a 36 fields · synced May 30, 2026