SURGICAL DRAPE

GUDID 08809783490419

UNICO GLOBAL INC

Surgical dressing/drape kit, single-use Surgical dressing/drape kit, single-use Surgical dressing/drape kit, single-use Surgical dressing/drape kit, single-use Surgical dressing/drape kit, single-use Surgical dressing/drape kit, single-use Surgical dressing/drape kit, single-use Surgical dressing/drape kit, single-use Surgical dressing/drape kit, single-use Surgical dressing/drape kit, single-use Surgical dressing/drape kit, single-use
Primary Device ID08809783490419
NIH Device Record Key16a97463-64d1-4a7c-a225-a75fc0b13208
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGICAL DRAPE
Version Model NumberSA-2001DR
Company DUNS690513726
Company NameUNICO GLOBAL INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809783490419 [Primary]

FDA Product Code

LYUAccessory, Surgical Apparel

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-28
Device Publish Date2022-03-18

Devices Manufactured by UNICO GLOBAL INC

08809783490105 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490112 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490129 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490136 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490143 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490150 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490167 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28
08809783490174 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)2022-03-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.