FDA.report

NOVO Health Services, LLC

Primary DI
00812564034496
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
125029
Catalog number
125029A
Device description
Set Up Pack, Adult Cath
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LROGeneral Surgery Tray

Product Code Classifications

CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812564034496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812564034496008125640344968125640344960812564034496

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, reusableA general-purpose collection of various sterile surgical instruments, dressings, and materials intended to be used to assist a range of surgical procedures across multiple clinical specialities. It does not contain pharmaceuticals. This is a reusable device.

Device Sizes

TypeValueUnit
Height9.5Inch
Weight7.7Pound
Width13Inch

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
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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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