FDA.report

SUMMIT MEDICAL

Primary DI
00385640048613
Brand
SUMMIT MEDICAL
Company
SUMMIT MEDICAL, INC.
Model
11S-S0800-08AS
Published
2021-04-15
Public version status
New
Distribution status
Not 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
00385640048613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640048613003856400486133856400486130385640048613

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
965484699
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
true
Sterilization required before use
false

Other Devices From This Company

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00385640091206INSTRUSAFEIN-3030-02532026-03-24
00385640091152INSTRUSAFEIN-2020-76872026-03-23
00385640091169INSTRUSAFEIN-2020-77092026-03-23
00385640091176INSTRUSAFEIN-2020-77212026-03-23
00385640091114INSTRUSAFEIN-2020-75572026-03-20
00385640091121INSTRUSAFEIN-2020-75562026-03-20
00385640091138INSTRUSAFEIN-2020-76112026-03-20
00385640091145INSTRUSAFEIN-2020-75882026-03-20
00385640090872INSTRUSAFEIN-2300-10-EN-1012026-03-19
00385640090889INSTRUSAFEIN-2300-10-EN-1022026-03-19
00385640090896INSTRUSAFEIN-2300-10-EN-1032026-03-19
00385640090902INSTRUSAFEIN-2300-10-EN-1042026-03-19
00385640090919INSTRUSAFEIN-2300-10-EN-1052026-03-19
00385640090926INSTRUSAFEIN-2300-10-EN-1062026-03-19
00385640090933INSTRUSAFEIN-2300-10-EN-1072026-03-19
00385640090940INSTRUSAFEIN-2300-10-EN-1082026-03-19
00385640090957INSTRUSAFEIN-2300-10-EN-1092026-03-19
00385640090964INSTRUSAFEIN-2300-10-EN-1102026-03-19

Other Devices Sharing Product Codes

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