FDA.reportPublic FDA data

BIVALVE SPLINT, LARGE THIN. SHORT - TERM USE UP TO 14 DAYS .25MM UHMW

Primary DI
00821925022157
Brand
BIVALVE SPLINT, LARGE THIN. SHORT - TERM USE UP TO 14 DAYS .25MM UHMW
Company
Gyrus Acmi, Inc.
Model
890918
Published
2018-09-13
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
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
00821925022157PackageGS112In Commercial Distribution
00821925040304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925022157008219250221578219250221570821925022157
00821925040304008219250403048219250403040821925040304

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 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
007198742
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
00821925043916SOLTIVETFL-FBX150BS2024-08-01
00821925043930SOLTIVETFL-FBX200S2024-08-01
00821925043978SOLTIVETFL-FBX200BS2024-08-01
00821925043992SOLTIVETFL-FBX365S2024-08-01
00821925044074SOLTIVETFL-FBX940S2024-08-01
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002098USA Elite SystemEOS-HCF252024-07-25
00821925002111USA Elite SystemERIS-CF252024-07-25
00821925002128USA Elite SystemERIS-CF272024-07-25
00821925002159USA Elite SystemERLB-7.52024-07-25
00821925002166USA Elite SystemEROS-CF252024-07-25
00821925002173USA Elite SystemEROS-CF272024-07-25
00821925002586Gyrus ACMI1942024-07-25
00821925007482Gyrus ACMIRFG-31152024-07-25
00821925008076Bovie5686012024-07-25
00821925008083Bovie5686042024-07-25
00821925008458Bovie5686052024-07-25
00821925008908Gyrus ACMIG2152-322024-07-25
00821925009523IRRI-FLO I 59200002024-07-25
00821925011427DIEGO703390502024-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
26975560670117Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670254Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670261Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670278Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670285Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670292Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670308Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
04250381820582Expanding headbandSpiggle & Theis Medizintechnik GmbHLYA2025-09-19
04250676712219Straight nasal tampon (exp.)Spiggle & Theis Medizintechnik GmbHLYA2025-09-19
04250676712233Straight nasal tampon (exp.)Spiggle & Theis Medizintechnik GmbHLYA2025-09-19
04250676731098Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-09-19
04250381808030Silicone SheetingSpiggle & Theis Medizintechnik GmbHLYA2025-09-12
04250381808047Silicone Sheeting, non-sterile, blueSpiggle & Theis Medizintechnik GmbHLYA2025-09-12
04250381808054Silicone sheetingSpiggle & Theis Medizintechnik GmbHLYA2025-09-12
04250381808061Silicone sheeting,Spiggle & Theis Medizintechnik GmbHLYA2025-09-12
04250381808078Silicone sheeting,Spiggle & Theis Medizintechnik GmbHLYA2025-09-12
04250381808085Silicone Sheeting, non-sterile, blueSpiggle & Theis Medizintechnik GmbHLYA2025-09-12
04250381846803Silicone plateSpiggle & Theis Medizintechnik GmbHLYA2025-09-12
04250381857816Silicone plateSpiggle & Theis Medizintechnik GmbHLYA2025-09-12
04250381809655Septal splintsSpiggle & Theis Medizintechnik GmbHLYA2025-09-09
04250381809662Septal splintsSpiggle & Theis Medizintechnik GmbHLYA2025-09-09
04250381809679Septal splintsSpiggle & Theis Medizintechnik GmbHLYA2025-09-09
04250381809785Septal splintsSpiggle & Theis Medizintechnik GmbHLYA2025-09-09