FDA.report

NOVO Health Services, LLC

Primary DI
00812564032485
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
123701
Catalog number
123701
Device description
ANESTHESIA N/S EMESIS BASIN
Published
2018-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FNYBasin, Emesis

Product Code Classifications

CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812564032485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812564032485008125640324858125640324850812564032485

GMDN Terms

TermDefinition
Sponge bowl, reusableA receptacle specifically designed to store and/or collect sponges; it may be used to collect sponges during a surgical procedure. It is typically made of stainless steel and can be used for multiple patients after appropriate sterilization. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
8138919550customerservice@novohealthservices.com

Regulatory Flags

DUNS number
069936106
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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