Device
Universal GPS Dish - (1 sleeve of 10) 1 pack with 10 dishes (Only sold in 1 pack)
Manufacturer
Coopersurgical, Inc.
Coopersurgical, Inc.
Model: UGPS-010M
Catalog: UGPS-010M
DI: 00888937029109
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Universal GPS Dish - (1 sleeve of 10) 1 pack with 10 dishes (Only sold in 1 pack)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cb0eaa0a-ab0a-4cdb-8506-dbdf102620e8
Distribution Status:
In Commercial Distribution
DUNS Number:
801895244
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00888937029109
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 56648
Name: Assisted reproduction procedure dish
Definition:
A container intended exclusively for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.
FDA Product Codes
MQK
LABWARE, ASSISTED REPRODUCTION
Premarket Submissions
Submission Number:
K080395
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Do not use if package is damaged
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Keep Dry