Identity
- Trade Name
- Sklar Instruments FDA UDI
- Generic Name
- Suturing needle holder, single-use FDA UDI
- Device Name
- ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25 FDA UDI
- Model / Reference
- 96-2352A FDA UDI
- Description
- ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10649111488153 FDA UDI
- FDA Product Code
- HXK FDA UDI
- GMDN Term
- Suturing needle holder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Suturing needle holder, single-use
Sklar Instruments by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suturing needle holder, single-use.
- Devon — Cardinal Health 200, LLC · Class I
- Needle Holder Troutman — BLINK MEDICAL LIMITED · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- CROWN SURGICAL — CROWN SURGICAL CORPORATION · Class I
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · Class I
- STRoPP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · 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
- Sklar Corporation
Sources (1)
- FDA UDI f0edf9d4-9d41-4510-b771-06d28e1e8685 33 fields · synced Jun 8, 2026