FDA.reportPublic FDA data

MEROCEL®

Primary DI
00681490105156
Brand
MEROCEL®
Company
MEDTRONIC XOMED, INC.
Model
400402
Device description
DRESSING 400402 20PK STD NASAL 8CM LONG
Published
2020-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFQGAUZE/SPONGE, INTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20681490105150PrimaryGS10
00681490105156Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068149010515020681490105150
00681490105156006814901051566814901051560681490105156

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
20
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
false
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
20763000888989Merocel4005152026-03-08
20763000888996Merocel4404122026-03-08
00763000892951M41898200T2026-02-28
00199150023851N/A8225101E2026-02-16
00199150023868N/A82251012026-02-16
00199150023875N/A82251102026-02-16
00199150023882N/A82251032026-02-16
00763000548797Hydrodebrider19140012026-02-14
00763000548803Hydrodebrider19210022026-02-14
20763000888910Merocel4001512026-02-15
20763000888927Merocel4001522026-02-15
00763000956028Tubing Set3318604E2026-02-14
00763000945671ApexCut187BL40002026-02-05
00763000945725ApexCut187BL40122026-02-05
00763000945749ApexCut187BL40402026-02-05
00643169547087NIM®82534022025-09-13
00763000745080NuVent™18INFKIT2025-08-15
00763000831479NIM™NIMDTP352025-08-11
20763000831480NIM™8225490X2025-08-11
20763000831497NIM™8225825X2025-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253067880ASOCardinal Health 200, LLCEFQ2026-01-20
00766588235745628 - Non-Stick Pads 2"x 3" - 4/unitCertified Safety Manufacturing, Inc.EFQ2025-12-17
30192253045905CurityCardinal Health 200, LLCEFQ2024-11-12
50192253045916CurityCardinal Health 200, LLCEFQ2024-09-10
10630094194117Bioseal Inc.BIOSEALEFQ2023-10-11
50192253047521CurityCardinal Health 200, LLCEFQ2023-10-09
50192253047569CurityCardinal Health 200, LLCEFQ2023-10-09
50732224004254Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004261Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004278Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004285Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004292Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004308Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004247All-Gauze Sponges PremiumCROSSTEX INTERNATIONAL, INC.EFQ2023-06-22
00766588110110637 - Certi-Gauze Pads - 3"x 3" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110141638 - Certi-Gauze Compress - 18"x 36" - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110172639 - Certi-Gauze Compress - 36"x 36" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110219640 - Certi-Gauze Compress - 24"x 72" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110301628 - Certi-Non-Stick Pads - 2"x 3" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588310039Certi-Non Stick Pads - 2"x 3" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312057Certi-Gauze Pads - 3"x 3" - 100/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312095Certi-Gauze Pads - 2"x 2" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312101Certi-Gauze Pads - 3"x 3" - 10/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312118Certi-Gauze Pads - 3"x 3" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312132Certi-Gauze Pads - 4"x 4" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110028622 - Certi-Gauze Bandage Compress - 2" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110059623 - Certi-Gauze Bandage Compress - 3" - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110080624 - Certi-Gauze Bandage Compress - 4" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110240634 - Certi-Gauze Roll - 2" x 6 yards - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110271635 - Certi-Gauze Roll - 4" x 6 yards - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27