Identity
- Trade Name
- ELITE MEDICAL INSTRUMENTATION FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Needleholder, Ryder, TC, Delicate, Serrated, 10 1/2" FDA UDI
- Model / Reference
- EMI-BM047R FDA UDI
- Description
- Needleholder, Ryder, TC, Delicate, Serrated, 10 1/2" FDA UDI
Identifiers
- Catalog Number
- EMI-BM047R NEEDLE HOLDER FDA UDI
- Primary DI / UDI-DI
- G569EMIBM047R0 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 — 10.5 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
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Also classified as Suturing needle holder, reusable.
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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 70b33f3f-fffb-40fd-a687-9601f94a6cd4 35 fields · synced May 30, 2026