Model: ZAV-1255-04
DI: 00197157077853
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
16X14 Sizer. 6 deg. 11 & 12 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:
ba11aa15-0760-4b1e-aaea-f39b34e3d023
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:
00197157077853
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47807
Name: Surgical implant/trial-implant/sizer holder, reusable
Definition:
A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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