FDA UDI In Commercial Distribution 🇺🇸 United States

SureLead

DI: B631DLSGGE4VL1M1 · Model: DLSGGE4VL1M · Authentic Medical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
SureLead
Primary DI
B631DLSGGE4VL1M1
Version / Model
DLSGGE4VL1M
Company Name
Authentic Medical
Labeler DUNS
078861998
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-10-22
Public Version
1
Public Version Date
2024-10-30
Public Version Status
New
Public Device Record Key
4d2d7ea8-cfd1-481a-acf6-7a65c26e647c

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DSA Cable, Transducer And Electrode, Patient, (Including Connector)

GMDN Terms

Code Name
61821 Electrocardiographic lead set, single-use

Identifiers

Type ID
Primary B631DLSGGE4VL1M1