Identity
- Trade Name
- ELITE MEDICAL INSTRUMENTATION FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Needleholder, Ryder, TC, XDelicate, Serrated, 155mm, 6" FDA UDI
- Model / Reference
- EMI-BM055R FDA UDI
- Description
- Needleholder, Ryder, TC, XDelicate, Serrated, 155mm, 6" FDA UDI
Identifiers
- Catalog Number
- EMI-BM055R NEEDLE HOLDER FDA UDI
- Primary DI / UDI-DI
- G569EMIBM055R0 FDA UDI
- FDA Product Code
- FHQ FDA UDI
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Inch FDA UDI
Category: Suturing needle holder, reusable
Elite Medical Instrumentation by Elite Medical Instrumentation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suturing needle holder, reusable.
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- BOSS Instruments — Boss Instruments, Ltd. · Class I
- S.C.A — SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ATLAS — ATLAS CERRAHİ ALETLER LTD. ŞTİ. · Class I
- Micro Needle Holders, STR SL lock DD, 0, 8 x 1, 4mm, Titan, 18cm — Cardio Surgical Ltd. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · 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 |
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Manufacturer
- Manufacturer
- Elite Medical Instrumentation
Sources (1)
- FDA UDI 8c46f0ef-0e5f-4c7e-9830-b5f034130045 35 fields · synced Jun 8, 2026