Model: SMAOCDCZAB
Catalog: SMAOCDCZAB
DI: 10198956458833
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
NW D AND C PACK
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b26da3ff-a435-42a7-ba56-20e04caf3e5e
Distribution Status:
In Commercial Distribution
DUNS Number:
961027315
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
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:
Yes
Identifiers
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
50198956458831
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
2
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10198956458833
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10198956458833
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 60644
Name: Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
Definition:
A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.
FDA Product Codes
PKF
D and C tray
Environmental Conditions
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
40
Storage Handling - Storage Handling Type:
Storage Environment Temperature