FDA.report

Suture Removal Kit

Primary DI
00616784452135
Brand
Suture Removal Kit
Company
DYNAREX CORPORATION
Model
4521
Device description
Suture Removal Kit, Sterile
Published
2021-06-21
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

Product Codes

CodeName
MCZSuture Removal Kit

Product Code Classifications

CodeDeviceSpecialtyClass
MCZSuture Removal KitGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784452135PackageGS150In Commercial Distribution
00616784452111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784452135006167844521356167844521350616784452135
00616784452111006167844521116167844521110616784452111

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

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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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