FDA.reportPublic FDA data

Neuray®

Primary DI
00763000032869
Brand
Neuray®
Company
MEDTRONIC XOMED, INC.
Model
8004009
Device description
PACKING 8004009 NEURAY 200PK 76X76MM
Published
2019-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923027000NEURAY SURGICAL PATTIES AND STRIPSMartland Healthcare, Inc.1992-08-28HBA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000032863PackageGS1200Not in Commercial Distribution
00763000032869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300003286320763000032863
00763000032869007630000328697630000328690763000032869

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque woven surgical spongeA non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Width0

Contacts#

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

Regulatory Flags#

DUNS number
835465063
Device count
1
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
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
00763000032784Neuray®80040002019-03-17
00763000032791Neuray®80040012019-03-17
00763000032807Neuray®80040022019-03-17
00763000032814Neuray®80040032019-03-17
00763000032821Neuray®80040042019-03-17
00763000032838Neuray®80040062019-03-17
00763000032845Neuray®80040072019-03-23
00763000843908NIM VitalNIM4CM012026-08-22
00763000843915NIM VitalNIM4CPB12026-08-22
00199150037407NIM™8225825X2026-03-29
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

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