Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Jaffe Needle Holder, Straight, w/o Lock, Delicate Conical Jaws EUDAMEDJaffe Needle Holder, Delicate Conical Jaws, Straight, without Lock FDA UDI
- Model / Reference
- S6-1090 EUDAMEDFDA UDI
- Description
- Jaffe Needle Holder, Delicate Conical Jaws, Straight, without Lock FDA UDI
Identifiers
- Catalog Number
- S6-1090 FDA UDI
- Primary DI / UDI-DI
- 00810799035936 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799035936 EUDAMED
- FDA Product Code
- HXK FDA UDI
- EMDN Code
- L010103 HANDLES FOR SCALPELS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Suturing needle holder, reusable
Stephens Instruments by Krishna Imports Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Krishna Imports Inc
Sources (2)
- FDA UDI a38c9308-1c99-4d32-b091-de8fef234d14 36 fields · synced Jul 31, 2026
- EUDAMED 36d42851-0915-4cb4-b997-7739ec2f48a2 61 fields · synced Jul 31, 2026