Identity
- Trade Name
- Heartline Suture Forceps FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Heartline Suture Forceps 1.2 Millimeter x 8.5 Millimeter Tungsten Carbide Dust Straight Jaw Without Lock Squeeze Handle FDA UDI
- Model / Reference
- 2800-335 FDA UDI
- Description
- Heartline Suture Forceps 1.2 Millimeter x 8.5 Millimeter Tungsten Carbide Dust Straight Jaw Without Lock Squeeze Handle FDA UDI
Identifiers
- Catalog Number
- 2800-335 FDA UDI
- Primary DI / UDI-DI
- 00192896110489 FDA UDI
- 510(k) Number
- K152400 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, 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 — 18 Centimeter FDA UDI
Category: Rigid endoscopic tissue manipulation forceps, reusable
Heartline Suture Forceps by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscopic tissue manipulation forceps, reusable.
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- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
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 CRILEWOOD NEEDLE HOLDER — 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.
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 e91eae81-614b-4a7c-abb0-c57672d7663a 37 fields · synced Jun 1, 2026