FDA.report

Medline

Primary DI
20888277385181
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
375747000R
Catalog number
375747000R
Device description
375-747-000 FRML END CTR RED/RED 4.0
Published
2022-05-12
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
HRXArthroscope

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277385181PackageGS15In Commercial Distribution
10888277385184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827738518120888277385181
1088827738518410888277385184

GMDN Terms

TermDefinition
Arthroscopic shaver system blade, reprocessedA sterile, powered, rotational, cutting device designed for use in an arthroscopic shaver system handpiece for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is locked into a handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector. The inner and outer tubes are typically made of high-grade stainless steel; the hub and connector may be made of stainless steel or a polymer [e.g., polyphenylsulfone (PPSU)]. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
025460908
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

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