FDA.report

Staple Removal Kit

Primary DI
00616784452234
Brand
Staple Removal Kit
Company
DYNAREX CORPORATION
Model
4522
Device description
Staple Removal Kit with Gauze Sponge
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00616784452234PackageGS150In Commercial Distribution
00616784452227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784452234006167844522346167844522340616784452234
00616784452227006167844522276167844522270616784452227

GMDN Terms

TermDefinition
Surgical staple remover, single-useA sterile surgical instrument that is used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a tweezers-like device made of high-grade stainless steel with blades at the distal end activated by lever action designed for grasping, opening, and removing surgical staples. 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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