FDA.report

MEDLINE

Primary DI
20193489112716
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
SR510
Catalog number
SR510
Device description
SUTURE REMOVAL KIT
Published
2021-11-12
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
MCZSuture removal kit

Product Code Classifications

CodeDeviceSpecialtyClass
MCZSuture Removal KitGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489112716PackageGS150In Commercial Distribution
10193489112719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348911271620193489112716
1019348911271910193489112719

GMDN Terms

TermDefinition
Suture removal kitA collection of various sterile instruments, dressings, and pharmaceuticals designed to remove sutures from a patient. It typically includes a disinfectant, scissors, forceps, gauze and bandages. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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