FDA.reportPublic FDA data

Sugi strips and sheets, sterile, sample

Primary DI
04260306710553
Brand
Sugi strips and sheets, sterile, sample
Company
QuestAlpha GmbH & Co. KG
Model
31710
Catalog number
31710
Device description
1 bag of REF 31711 Sugi Rhino Strips, 200 x 15 mm, sterile, 20 x 1 pc.1 bag of REF 31721 Sugi Rhino Sheets, 80 x 90 mm, sterile, 10 x 1 pc.
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
04260306710553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260306710553042603067105534260306710553

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

Contacts#

Phone, Email table
PhoneEmail
+4927747050info@questalpha.com

Regulatory Flags#

DUNS number
342894795
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260306710485Sugi31005310052023-07-24
04260306710492Sugi31604316042023-07-24
04260306710515Sugi Rhino Swabs and. Endopads, sterile, sample31784317842025-08-15
04260306710522Sugi sterile, sample, ophthalmology30001300012025-08-15
04260306710430Sugi30672306722019-09-06
04260306710454Sugi30674306742019-09-06
04260306710577Sugi31962319622024-12-02
04260306710584Sugi31963319632024-12-02
04260306710508Sugi31963319632023-06-01
04260306710263Sugi31962319622023-04-05
04260306710478Sugi31004310042024-07-31
04260306710164Sugi30761307612024-07-08
04260306710423Sugi30671306712019-09-06
04260306710324Sugi30616306162018-03-22
04260306710331Sugi30617306172018-03-22
04260306710102Sugi31602316022016-09-15
00426030671032Sugi30616306162023-07-26
04260306710072Sugi31002310022023-07-24
04260306710010Sugi30603306032016-09-15
04260306710126Sugi32102321022023-05-23

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Primary DI, Brand, Company table
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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
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