Generic
GUDID D8305508122
TYVEK H/S POUCH 8" X 12"
GS Medical Packaging Inc
Sterilization packaging, single-use| Primary Device ID | D8305508122 |
| NIH Device Record Key | ac799280-659c-4376-b4c9-83613f2f1847 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Generic |
| Version Model Number | 550812 |
| 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 | true |
| 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 | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D830550812 [Primary] |
| HIBCC | D8305508121 [Package] Contains: D830550812 Package: POLY BAG [200 Units] In Commercial Distribution |
| HIBCC | D8305508122 [Package] Contains: D8305508121 Package: CARDBOARD BOX [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K953829
FDA Product Code
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-10-06 |
On-Brand Devices [Generic]
| D8305716202 | TYVEK AUTOCLAVABLE BAG 15.75"X18.25" |
| D8305711142 | TYVEK AUTOCLAVABLE BAG 11"X13.75" |
| D8305612182 | TYVEK S/S POUCH 12" X 18" |
| D8305612152 | TYVEK S/S POUCH 12" X 15" |
| D8305608132 | TYVEK S/S POUCH 7.5" X 13" |
| D8305605102 | TYVEK S/S POUCH 5.25" X 10" |
| D8305518311 | TYVEK H/S POUCH 18" X 31" |
| D830551442PC0 | TYVEK ROLL 12"X200' |
| D8305514420 | TYVEK ROLL 12" X 100' |
| D8305514400 | TYVEK ROLL 10" X 100' |
| D8305514380 | TYVEK ROLL 8" X 100' |
| D830551436PC0 | TYVEK ROLL 6"X200' |
| D8305514360 | TYVEK ROLL 6" X 100' |
| D8305514340 | TYVEK ROLL 4" X 100' |
| D8305514330 | TYVEK ROLL 3" X 100' |
| D8305514320 | TYVEK ROLL 2" X 100' |
| D8305512182 | TYVEK H/S POUCH 12" X 18" |
| D8305512152 | TYVEK H/S POUCH 12" X 15" |
| D830551015T2 | TYVEK H/S POUCH 10" X 15" |
| D8305510152 | TYVEK H/S POUCH 10" X 15" |
| D8305508122 | TYVEK H/S POUCH 8" X 12" |
| D8305506102 | TYVEK H/S POUCH 6" X 10 |
| D8305506072 | TYVEK H/S POUCH 6" X 7" |
| D8305504092 | TYVEK H/S POUCH 4" X 9" |
| D8305503072 | TYVEK H/S POUCH 3" X 7" |
| D8305503052 | TYVEK H/S POUCH 3" X 5" |
Trademark Results [Generic]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.