FDA UDI Not in Commercial Distribution 🇺🇸 United States

SPRINT™

DI: 00854001007052 · Model: Lead Connector and Wrench · SPR THERAPEUTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SPRINT™
Primary DI
00854001007052
Version / Model
Lead Connector and Wrench
Catalog Number
9189-CME
Company Name
SPR THERAPEUTICS, INC.
Labeler DUNS
963383778
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-01-19
Public Version
8
Public Version Date
2023-07-24
Public Version Status
Update
Public Device Record Key
881bc1de-7a38-4a20-8725-6d4b011b2c32
Distribution End Date
2023-07-21

Device Description

SPRINT™ Lead Connector and Wrench

Device Characteristics

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
NHI Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief

GMDN Terms

Code Name
60959 Analgesic PENS system

Identifiers

Type ID
Primary 00854001007052

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-20 – 55 Degrees Celsius
Type
Handling Environment Temperature
Temperature Range
-20 – 55 Degrees Celsius