FDA UDI In Commercial Distribution 🇺🇸 United States

N/A

DI: 00643169986473 · Model: 355560 · MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
N/A
Primary DI
00643169986473
Version / Model
355560
Company Name
MEDTRONIC, INC.
Labeler DUNS
796986144
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-03
Public Version
2
Public Version Date
2024-02-05
Public Version Status
Update
Public Device Record Key
1f7ee1e0-b5f4-4afb-8ac6-89fec2ee7682

Device Description

ACCY KIT 355560 SCS EXTNSION PASSER 60CM

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GZB STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

GMDN Terms

Code Name
46801 Subcutaneous tunneller, single-use

Identifiers

Type ID
Primary 00643169986473

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K000105 000

Device Sizes

Type Value Unit Text
Length 60.0 Centimeter