FDA.report

MEDLINE

Primary DI
20197344167330
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
NEUROSPNG15
Catalog number
NEUROSPNG15
Device description
SPONGE,NEURO,3"X3",XR,STRL,LF,10/PK
Published
2025-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HBANeurosurgical paddie

Product Code Classifications

CodeDeviceSpecialtyClass
HBANeurosurgical PaddieNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344167330PackageGS120In Commercial Distribution
10197344167333PrimaryGS10
80197344167332Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734416733020197344167330
1019734416733310197344167333
8019734416733280197344167332

GMDN Terms

TermDefinition
Neurosurgical spongeA sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
10
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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