Device
Tissue, One Compartment, 5.0 x 1.0 mm, 45°, Lid Attached, Front Hinge, rounded tab, Raised, White, Taped (for IR Laser)
Manufacturer
TYPENEX MEDICAL LLC
TYPENEX MEDICAL LLC
Model: EC0616WXT-LASER
DI: 10810050855928
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
Tissue, One Compartment, 5.0 x 1.0 mm, 45°, Lid Attached, Front Hinge, rounded tab, Raised, White, Taped (for IR Laser)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
48ad084d-80b7-42a5-86e8-fb118ed15f97
Distribution Status:
In Commercial Distribution
DUNS Number:
600850213
Device Count:
2000
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00810050855921
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10810050855928
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 63791
Name: Tissue embedding mould IVD, single-use
Definition:
A plastic container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of synthetic polymer materials (e.g., plastic) This is a single-use device.
FDA Product Codes
IDZ
Cassettes, Tissue