Primary Device ID | D830500000112 |
NIH Device Record Key | b94e6e46-2fdf-48ac-ba90-5f3824669d1e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Element Self Sealing Sterilization Pouch |
Version Model Number | 500-00011 |
Catalog Number | 500-00011 |
Company DUNS | 246113039 |
Company Name | GS Medical Packaging Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 905.271.1523 |
hamed@hedygs.com | |
Phone | 905.271.1523 |
hamed@hedygs.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D830500000110 [Primary] |
HIBCC | D830500000111 [Package] Contains: D830500000110 Package: Box [200 Units] In Commercial Distribution |
HIBCC | D830500000112 [Package] Contains: D830500000111 Package: Case [6 Units] In Commercial Distribution |
KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-11-26 |
Device Publish Date | 2019-11-18 |
D830500000112 | Self Sealing Sterilization Pouch 5.25’’ x 10” (13.3 cm x 25.4 cm) |
D830500000102 | Self Sealing Sterilization Pouch Size: 3.5’’ x 10” (8.9cm x 25.4cm) |
D830500000091 | Self Sealing Sterilization Pouch 2.75’’ x 10” |
D83050000081 | Self Sealing Sterilization Pouch 3.5"X5.5" |