FDA.report

MEDLINE

Primary DI
20888277378367
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
9971R
Catalog number
9971R
Device description
9971 @CTS RELIEF KIT
Published
2025-02-14
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
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277378367PackageGS14In Commercial Distribution
10888277378360PrimaryGS10
80888277378369Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827737836720888277378367
1088827737836010888277378360
8088827737836980888277378369

GMDN Terms

TermDefinition
Hand ligament surgical release instrumentA hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
025460908
Device count
4
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
false
Sterilization required before use
false

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