FDA.report

NovaShield™

Primary DI
00643169347373
Brand
NovaShield™
Company
MEDTRONIC XOMED, INC.
Model
CG1000
Device description
NASAL PAK-STENT CG1000 NOVASHIELD INJECT
Published
2016-04-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LYASPLINT, INTRANASAL SEPTAL

Product Code Classifications

CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00643169347373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169347373006431693473736431693473730643169347373

GMDN Terms

TermDefinition
ENT space-occupying dressing, animal-derivedA sterile, bioabsorbable material intended to be used to help heal tissue, limit adhesions between mucosal surfaces, and control bleeding after ear/nose/throat (ENT) surgery or trauma. It is typically available as a gel or gelatin sponge; it contains animal-derived components (e.g., collagen), and may additionally contain microbe-derived (biosynthetic) components [e.g., hyaluronic acid (HA)]. In nasal/sinus applications it may be aspirated (removed) from the cavity before absorption.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
835465063
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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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