NOVO Health Services, LLC 124012

GUDID 00812564039507

STD GOWNS, XXLG 22 PK N/S

NOVO HEALTH SERVICES, LLC

Isolation gown, reusable
Primary Device ID00812564039507
NIH Device Record Keybb00b918-cd4e-4dbf-b1f3-92dec4038ef9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVO Health Services, LLC
Version Model Number124012
Catalog Number124012
Company DUNS069936106
Company NameNOVO HEALTH SERVICES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8138919550
Emailcustomerservice@novohealthservices.com
Phone8138919550
Emailcustomerservice@novohealthservices.com

Device Dimensions

Height13 Inch
Height13 Inch
Height13 Inch
Height13 Inch
Height13 Inch
Height13 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100812564039507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

On-Brand Devices [NOVO Health Services, LLC]

0081256403999625 TOWELS, DISP, BLUE (FF) N/S
00812564039989SPLIT DRAPE (3 X 26)
00812564039972U-BAR DRAPE SYSTEM
00812564039965PERI PACK
008125640399585 LG GOWNS, SM N/S
008125640399415 LP GOWNS, XXL N/S
008125640399345 LP GOWNS, XLG N/S
008125640399275 LP GOWNS, LG N/S
008125640399105 LP GOWNS, MED N/S
008125640399035 LARGE SHEET PACK N/S
00812564039897Gown, L2 XXL, 5-Pack NS
00812564039880Gown, L2 XL, 5-Pack NS
00812564039873Gown, L2 LG, 5-Pack NS
00812564039866Gown, L2 M, 5-Pack NS
00812564039859Gown, L2 S, 5-Pack NS
00812564039842Gown, L4 XXL, 5-Pack NS
00812564039835Gown, L4 XL, 5-Pack NS
00812564039828Gown, L4 LG, 5-Pack NS
00812564039811Gown, L4 M, 5-Pack NS
00812564039804Gown, L4 XL, 20-Pack NS
00812564039798Gown, L4 LG, 24-Pack NS
00812564039781Gown, L4 M, 24-Pack NS
00812564039774L3 5/PK PREMIUM GOWNS XXLG NS
00812564039767L3 5/PK PREMIUM GOWNS MED NS
00812564039750Gown, L3 XL, 24-Pack NS
00812564039743Gown, L3 LG, 24-Pack NS
0081256403973624PK L3 PREMIUM GOWNS MED NS
00812564039729L3 5 PLR GOWNS, MED N/S
008125640397122 LP GOWNS, LARGE W/PAPER TWL
00812564039705Towel, White, 100-CT NS
00812564039699PREM L4 GOWNS, LG 10 PK N/S
00812564039682LP GOWNS, LG 10 PK N/S
00812564039675PREM L4 GOWNS, XLG 10 PK N/S
00812564039668LP GOWNS, XLG 10 PK N/S
00812564039651BABY BLANKET PACK
00812564039644Gown, L4 XXL, 15-Pack NS
00812564039637Gown, L4 LG, 15-Pack NS
00812564039620Gown, L4 XL, 15-Pack NS
00812564039613Gown, L4 M, 15-Pack NS
00812564039606CIRCUMCISION DRAPES 5 PK (NS)
00812564039590Towel QF, 50-Pack NS, Tote
00812564039583STD GOWN, XLG 2 PK W/TOWELS
0081256403957650 COUNT TOWEL PK(FF), NS TOTE
00812564039569GreenWrap 54X54 (10 PK) NS
00812564039552GreenWrap 48X48 (20 PK) NS
00812564039545GreenWrap 36X36 (20 PK) NS
00812564039538GreenWrap 24X24 (20 PK) NS
00812564039521CENTRAL UTAH 25 TOWEL PK N/S
008125640395144 LP GOWNS, LG W/TWL
00812564039507STD GOWNS, XXLG 22 PK N/S
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