FDA.reportPublic FDA data

Merocel

Primary DI
20643169724901
Brand
Merocel
Company
MEDTRONIC XOMED, INC.
Model
300510
Device description
SPONGE 300510 MEROCEL 100PK 2.5 X 7.6CM
Published
2016-05-09
Public version status
Update
Distribution status
Not 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
HBANEUROSURGICAL PADDIE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBANeurosurgical PaddieNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20643169724901PackageGS1100In Commercial Distribution
00643169724907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2064316972490120643169724901
00643169724907006431697249076431697249070643169724907

GMDN Terms#

Term, Definition table
TermDefinition
Cottonoid padA cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length76Millimeter
Width25Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
835465063
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12
20763000041544NIM TriVantage®82297392020-02-29
00763000033972NIM TriVantage®82297092020-02-15
20681490055158Merocel®22185352017-10-16
00643169782617NIM Trivantage®82297092016-11-12
00613994176547Reuter10103012015-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000663292ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663308ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663346ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663353ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663360ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663735ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
M731K90019Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90049Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90059Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90069Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90079Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90089Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90099Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90109Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90159Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90169Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90179Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90189Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90199Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90209Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90219Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90229Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90239Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90269Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90279Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90289Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90299Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90509Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90519Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90529Spetzler Neuro PattiesOMT, LLCHBA2025-12-31