FDA UDI In Commercial Distribution 🇺🇸 United States

MIS Bunion - 1.6mm Guide Wire (x2) (47-0031-S)

DI: 00850078396037 · Model: 1032-004 · Eca Medical Instruments
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
MIS Bunion - 1.6mm Guide Wire (x2) (47-0031-S)
Primary DI
00850078396037
Version / Model
1032-004
Catalog Number
1032-004
Company Name
Eca Medical Instruments
Labeler DUNS
084330422
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-11-11
Public Version
1
Public Version Date
2025-11-19
Public Version Status
New
Public Device Record Key
7a0089fe-4bec-4fb7-b634-3453d82673e3

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
44052 Orthopaedic surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Primary 00850078396037