FDA.report

MEROCEL®

Primary DI
00681490115063
Brand
MEROCEL®
Company
MEDTRONIC XOMED, INC.
Model
470405
Device description
PACKING 470405 MEROCEL 2000 10PK 8CM
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

Related Records

Contact Domains

Product Codes

CodeName
EFQGAUZE/SPONGE, INTERNAL

Product Code Classifications

CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20681490115067PrimaryGS10
00681490115063Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2068149011506720681490115067
00681490115063006814901150636814901150630681490115063

GMDN Terms

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

TypeValueUnit
Length8Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
835465063
Device count
10
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

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Other Devices Sharing Product Codes

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