Model: 023470
Catalog: 023470
DI: 00850012846703
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
PicoDriver Device Straight
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
db7b4797-3480-40b5-881a-72ec88f43fb5
Distribution Status:
In Commercial Distribution
DUNS Number:
603420183
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
10850012846700
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
8
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00850012846703
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00850012846703
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 57874
Name: Suturing unit, single-use
Definition:
A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.
FDA Product Codes
GDF
GUIDE, NEEDLE, SURGICAL