Model: ZAV-1255-03
DI: 00197157077846
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
16X14 Sizer. 6 deg. 9 & 10 mm
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
38afd8f6-0e9a-4e9b-9a20-c941d86da920
Distribution Status:
In Commercial Distribution
DUNS Number:
069472800
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00197157077846
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47809
Name: Percutaneous electrical stimulation lead external pulse generator cable, reusable
Definition:
A noninvasive electrically-insulated wire intended to enable an electrical connection between an external pulse generator (EPG) of a [trial] implantable electrical stimulation system (e.g., intramuscular diaphragm/phrenic nerve or a spinal/peripheral nerve electrical stimulation system) and the proximal end of a percutaneously implanted lead, to permit the transmission of the electrical pulses and to create a return path to the EPG. This is a reusable device.
FDA Product Codes
ODP
Intervertebral Fusion Device With Bone Graft, Cervical
MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
Premarket Submissions
Submission Number:
K181244
Supplement Number:
000