FDA.reportPublic FDA data

Merocel™

Primary DI
20763000616735
Brand
Merocel™
Company
MEDTRONIC XOMED, INC.
Model
400402
Device description
DRESSING 400402 MEROCEL 20PK STD NASAL 8
Published
2022-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFQGAUZE/SPONGE, INTERNAL
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000616735PrimaryGS10
00763000616731Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300061673520763000616735
00763000616731007630006167317630006167310763000616731

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; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Centimeter

Contacts#

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

Regulatory Flags#

DUNS number
835465063
Device count
20
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169644656Otomag™ Attract™ Magnetic SpacerS0266-002016-04-15
00643169644663Otomag™ Attract™ Magnetic SpacerS0266-012016-04-15
00643169644670Otomag™ Attract™ Magnetic SpacerS0266-022016-04-15
00643169644687Otomag™ Attract™ Magnetic SpacerS0266-032016-04-15
00643169644694Otomag™ Attract™ Magnetic SpacerS0266-042016-04-15
00643169644700Otomag™ Attract™ Magnetic SpacerS0266-052016-04-15
00643169644717Otomag™ Attract™ Magnetic SpacerS0266-062016-04-15
00643169644731Otomag™ Attract™ Magnetic SpacerS0266-082016-04-15
00643169644748Otomag™ Attract™ Magnetic SpacerS0266-092016-04-15
00643169644755Otomag™ Attract™ Magnetic SpacerS0266-102016-04-15
00643169644762Otomag™ Attract™ Magnetic SpacerS0266-112016-04-15
00643169644779Otomag™ Attract™ Magnetic SpacerS0266-152016-04-15
00643169644786Otomag™ Attract™ Magnetic SpacerS0266-212016-04-15
00643169644793Otomag™ Attract™ Magnetic SpacerS0542-002016-04-15
00643169644809Otomag™ Attract™ Magnetic SpacerS0542-012016-04-15
00643169644816Otomag™ Attract™ Magnetic SpacerS0542-022016-04-15
00643169644823Otomag™ Attract™ Magnetic SpacerS0542-032016-04-15
00643169644830Otomag™ Attract™ Magnetic SpacerS0542-042016-04-15
00643169644847Otomag™ Attract™ Magnetic SpacerS0542-052016-04-15
00643169644854Otomag™ Attract™ Magnetic SpacerS0542-062016-04-15

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