Primary Device ID | 20376885024016 |
NIH Device Record Key | d6b89d6b-546e-43a1-8223-250e19657000 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Shoe cover (33gsm PP full elastic) [EMS-10211] |
Version Model Number | EMS-10211 |
Company DUNS | 117478411 |
Company Name | Emergency Medical Solutions LLC |
Device Count | 1000 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00376885024012 [Unit of Use] |
GS1 | 20376885024016 [Primary] |
FXP | Cover, Shoe, Operating-Room |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-20 |
Device Publish Date | 2021-05-12 |
20376885018015 - Knee high boot covers (45g SMS) | 2021-05-20 knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms, elastic at ankle) [EMS-11211B] |
20376885019012 - Knee high boot covers (45g SMS) | 2021-05-20 knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms (welded), Tie to tighten boat) [EMS-11222] |
20376885020018 - Knee high boot covers (45g SMS) | 2021-05-20 knee high boot covers (45g SMS + 2 strips EVA non skid bottom) [EMS-11211] |
20376885021015 - Knee high boot cover (40g SMS) | 2021-05-20 Knee high boot cover (40g SMS + pvc non slip) [EMS-11311] |
20376885022012 - Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411] | 2021-05-20 Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411] |
20376885023019 - Shoe cover (35gsm PP half elastic) [EMS-10221] | 2021-05-20 Shoe cover (35gsm PP half elastic) [EMS-10221] |
20376885024016 - Shoe cover (33gsm PP full elastic) [EMS-10211] | 2021-05-20 |
20376885024016 - Shoe cover (33gsm PP full elastic) [EMS-10211] | 2021-05-20 |
20376885025013 - Shoe cover (40gsm PP half elastic) [EMS-10232] | 2021-05-20 Shoe cover (40gsm PP half elastic) [EMS-10232] |