FDA.reportPublic FDA data

XeroGel

Primary DI
00857326005543
Brand
XeroGel
Company
ENTELLUS MEDICAL, INC.
Model
XG-108
Device description
Nasal Epistaxis 8 Pack
Published
2020-09-10
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113585000NASAL/EPISTAXIS PACKCogent Therapeutics, LLC2012-04-25LYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857326005540PrimaryGS10
00857326005543Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085732600554010857326005540
00857326005543008573260055438573260055430857326005543

GMDN Terms#

Term, Definition table
TermDefinition
ENT space-occupying dressing, animal-derivedA sterile, bioabsorbable material intended to be used to help heal tissue, limit adhesions between mucosal surfaces, and control bleeding after ear/nose/throat (ENT) surgery or trauma. It is typically available as a gel or gelatin sponge; it contains animal-derived components (e.g., collagen), and may additionally contain microbe-derived (biosynthetic) components [e.g., hyaluronic acid (HA)]. In nasal/sinus applications it may be aspirated (removed) from the cavity before absorption.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017283879
Device count
8
DM exempt
false
Premarket exempt
false
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
00857326005536XeroGelXG-1022020-09-10
10850002250210Shaver Blade 2.1mm Reusable Double Serrated StraightSSB-222-02020-09-25
10857326005731Shaver Blade 3mm Reusable Double Serrated Straight SSB-223-02020-09-25
10857326005748Shaver Blade 4mm Reusable Double Serrated Straight SSB-224-02020-09-25
10857326005755Shaver Blade 3mm Single Use Double Serrated StraightSSB-12300-1, SSB-12300-52020-09-25
10857326005762Shaver Blade 3mm Single Use Double Serrated 40° SSB-12340-1, SSB-12340-52020-09-25
10857326005779Shaver Blade 3mm Single Use Double Serrated 60°SSB-12360-1, SSB-12360-52020-09-25
10857326005786Shaver Blade 4mm Single Use Double Serrated Straight SSB-12400-1, SSB-12400-52020-09-25
10857326005793Shaver Blade 4mm Single Use Double Serrated 40° SSB-12440-1, SSB-12440-52020-09-25
10857326005809Shaver Blade 4mm Single Use Double Serrated 60° SSB-12460-1, SSB-12460-52020-09-25
10857326005830Shaver Blade 2.1mm Single Use Double Serrated StraightSSB-12200-1, SSB-12200-52020-09-25
00857326005550Entellus Medical Reinforced Anesthesia Needle RANRAN-027-22017-05-18
00857326005574Entellus Medical Reinforced Anesthesia Needle RANRAN-027-52017-05-18
00857037006990LATERALATDD012016-07-21
00857037006983LATERALATANI012016-07-21
00857037006921LATERALATDD242017-09-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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