FDA.report

EXMOOR

Primary DI
05060180251123
Brand
EXMOOR
Company
EXMOOR PLASTICS LIMITED
Model
N4
Catalog number
N4
Device description
Nasal Splint
Published
2018-09-14
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

Contact Domains

Product Codes

CodeName
LYASplint, Intranasal Septal

Product Code Classifications

CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060180251123PackageGS120In Commercial Distribution
05060180257613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060180251123050601802511235060180251123
05060180257613050601802576135060180257613

GMDN Terms

TermDefinition
Intranasal splint, non-biodegradableA sterile, 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep out of direct sunlight.
Special Storage Condition, Specify00Store in a dry environment. Avoid extremes of temperature and humidity.
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+441823351040sales@exmoorltd.com

Regulatory Flags

DUNS number
298725490
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
true
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 DIBrandModelCatalogPublished
05060180251055EXMOORSC4JHSC4JH2022-05-12
05060180259457EXMOORMK73MK732022-05-12
05060180250447EXMOORS1S12018-09-11
05060180250072EXMOORS1001/640S1001/6402018-09-14
05060180250041EXMOORS1005/290S1005/2902018-09-14
05060180250058EXMOORS1005/490S1005/4902018-09-14
05060180250232EXMOORS101S1012018-09-11
05060180250096EXMOORS1010/290S1010/2902018-09-14
05060180250027EXMOORS1010/340S1010/3402018-09-14
05060180250034EXMOORS1010/540S1010/5402018-09-14
05060180250089EXMOORS1011/300S1011/3002018-09-14
05060180250010EXMOORS1011/390S1011/3902018-09-14
05060180250003EXMOORS1012/300S1012/3002018-09-14
05060180250249EXMOORS102S1022018-09-11
05060180250256EXMOORS103S1032018-09-11
05060180250263EXMOORS104S1042018-09-11
05060180250270EXMOORS105S1052018-09-11
05060180250287EXMOORS106S1062018-09-11
05060180250294EXMOORS107S1072018-09-11
05060180250300EXMOORS108S1082018-09-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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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
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