FDA.report

Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing

Primary DI
10818501021069
Brand
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing
Company
INVOTEC INTERNATIONAL, INC.
Model
20-10682S
Catalog number
20-10682S
Device description
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.020" Singles
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LYASplint, Intranasal Septal

Product Code Classifications

CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818501021069PackageGS110In Commercial Distribution
00818501021062PrimaryGS10

GMDN Terms

TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
622812592
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10818501021168Invotec Silicone Sheeting20-2068020-206802022-12-07
10818501021175Invotec Silicone Sheeting20-2068220-206822022-12-07
10818501021182Invotec Silicone Sheeting20-2068520-206852022-12-07
00818501021208Invotec Silicone Sheeting20-3000220-300022022-12-07
00818501021215Invotec Silicone Sheeting20-3000520-300052022-12-07
00818501021222Invotec Silicone Sheeting20-3000720-300072022-12-07
00818501021239Invotec Silicone Sheeting20-3001020-300102022-12-07
00818501021246Invotec Silicone Sheeting20-3001520-300152022-12-07
00818501021253Invotec Silicone Sheeting20-3002020-300202022-12-07
00818501021260Invotec Silicone Sheeting20-3003020-300302022-12-07
00818501021277Invotec Silicone Sheeting20-3004020-300402022-12-07
00818501021284Invotec Silicone Sheeting20-3005020-300502022-12-07
00818501021291Invotec Silicone Sheeting20-3006020-300602022-12-07
00818501021307Invotec Silicone Sheeting20-30040R20-30040R2022-12-07
00818501021314Invotec Silicone Sheeting20-30030R20-30030R2022-12-07
00818501021321Invotec Silicone Sheeting20-30020R20-30020R2022-12-07
00818501021338Invotec Silicone Sheeting20-30015R20-30015R2022-12-07
00818501021345Invotec ENT BurBC-70050BC-705002022-12-07

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