FDA.reportPublic FDA data

Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing

Primary DI
10818501020888
Brand
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing
Company
INVOTEC INTERNATIONAL, INC.
Model
27-10001
Catalog number
27-10001
Device description
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing 1.60" X 0.24" X 0.005"
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

Product Codes#

Code, Name table
CodeName
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818501020888PackageGS130In Commercial Distribution
00818501020881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081850102088810818501020888
00818501020881008185010208818185010208810818501020881

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818501023158Invotec Forceps 129-808002023-07-18
00818501021161Invotec Silicone Sheeting20-2068020-206802022-12-07
00818501021178Invotec Silicone Sheeting20-2068220-206822022-12-07
00818501021185Invotec Silicone Sheeting20-2068520-206852022-12-07
00818501021956Invotec PVA Nasal Dressing22-6040022-604002022-12-07
00818501021963Invotec PVA Nasal Dressing22-60400P22-60400P2022-12-07
00818501021970Invotec PVA Nasal Dressing22-6040222-604022022-12-07
00818501021987Invotec PVA Nasal Dressing22-60402P22-60402P2022-12-07
00818501021994Invotec PVA Nasal Dressing22-6040622-604062022-12-07
00818501022007Invotec PVA Nasal Dressing22-60406P22-60406P2022-12-07
00818501022014Invotec PVA Nasal Dressing22-6040922-604092022-12-07
00818501022021Invotec PVA Nasal Dressing22-60409P22-60409P2022-12-07
00818501022038Invotec PVA Nasal Dressing22-6041022-604102022-12-07
00818501022045Invotec PVA Nasal Dressing22-60410P22-60410P2022-12-07
00818501022052Invotec PVA Nasal Dressing22-6041122-604112022-12-07
00818501022069Invotec PVA Nasal Dressing22-60411P22-60411P2022-12-07
00818501022076Invotec PVA Nasal Dressing22-6041322-604132022-12-07
00818501022083Invotec PVA Nasal Dressing22-60413P22-60413P2022-12-07
00818501022090Invotec PVA Nasal Dressing22-6041422-604142022-12-07
00818501022106Invotec PVA Nasal Dressing22-6042122-604212022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850056665305ORCA FoamOrca Products, LLCLYA2026-05-07
16975560670042Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670059Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670066Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670073Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670080Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670097Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670103Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670110Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670257Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670264Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670271Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670288Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670295Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670301Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670045Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670052Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670069Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670076Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670083Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670090Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670100Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
04250381820537Expanding sinus tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250381820544Expanding sinus tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676730008MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731104Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731111Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731128Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731135Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676741691Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07