FDA.report

PENDING

Primary DI
10080196013128
Brand
PENDING
Company
MEDLINE INDUSTRIES, INC.
Model
MPN50012
Catalog number
MPN50012
Device description
TISSUE PROTECTOR, 2.8MM/3.5MM
Published
2020-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10080196013128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1008019601312810080196013128

GMDN Terms

TermDefinition
Nerve guide, non-bioabsorbableAn implantable tubular device, typically made of silicone rubber, intended to be used to encase a nerve for protection to aid in repair (e.g., to prevent ingrowth of scar tissue), or for capping the end of an amputated nerve to prevent the formation of painful neuroma (tumours). It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

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10197344039890MEDLINEHNY22100HNY221002024-10-11
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10197344099771MEDLINEAVT0665AVT06652025-03-10

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