FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10198459122644
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJZ150567
Catalog number
DYNJZ150567
Device description
SPNG NEURO .75X.75 XR 10/PK
Published
2024-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K193346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193346000Codman Surgical Patties & StripsIntegra LifeSciences Corporation2020-11-20HBA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459122645PackageGS120In Commercial Distribution
10198459122644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845912264540198459122645
1019845912264410198459122644

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15
10653160394433MEDLINEEBSI1364BEBSI1364B2026-10-15

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
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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