Device
Gemini Two Ply Bonded Sterilization Wrap, Lightweight, 40inX40in
Manufacturer
MEDLINE INDUSTRIES, INC.
MEDLINE INDUSTRIES, INC.
Model: GEM1140S
Catalog: GEM1140S
DI: 20080196181565
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2016-10-14
Current Version: 2026-05-05
Description
Gemini Two Ply Bonded Sterilization Wrap, Lightweight, 40inX40in
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
4
Record Key:
0fb25dfd-ee4b-4745-99f2-eb70d056c39a
Distribution Status:
In Commercial Distribution
DUNS Number:
025460908
Device Count:
20
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
20080196181565
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
CS
Item #2 - Device ID:
40080196181569
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
5
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
20080196181565
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
10080196181568
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 13735
Name: Sterilization packaging, single-use
Definition:
A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.
FDA Product Codes
FRG
Wrap, sterilization