Identity
- Trade Name
- Needle Holder FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
- Device Name
- Needle Holder With Tungsten Carbide Serrated Crosswise Teeth Right Curved Single Action Jaw FDA UDI
- Model / Reference
- 2901-323L FDA UDI
- Description
- Needle Holder With Tungsten Carbide Serrated Crosswise Teeth Right Curved Single Action Jaw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896112285 FDA UDI
- 510(k) Number
- K102921 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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 — 450 Millimeter FDA UDI
Category: Endoscopic electrosurgical electrode, monopolar, reusable
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
K102921 also covers:
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
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 1aacf61f-11cc-479a-9592-24725983014b 36 fields · synced May 31, 2026