FDA.report

Taiwan Surgical

Primary DI
04717480900374
Brand
Taiwan Surgical
Company
TAIWAN SURGICAL CORPORATION
Model
TSR-120-R
Published
2023-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GDTStaple, Removable (Skin)

Product Code Classifications

CodeDeviceSpecialtyClass
GDTStaple, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04717480900374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04717480900374047174809003744717480900374

GMDN Terms

TermDefinition
Skin staple remover, single-useA hand-held manual surgical instrument intended to be 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 metallic or synthetic polymer materials 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
657134172
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04717480902347InnoClipRC5T1-B62023-07-11
04717480902354InnoClipRC5T1-BX2023-07-11
04717480906024SkinPlusDP0S1-SR2023-07-11
04717480906031SkinPlusDP0S1-SW2023-07-11
14717480902016InnoClipTDC-10-ML2023-07-11
14717480902023InnoClipTDC-10-L2023-07-11
14717480902306InnoClipTRC-H00002023-07-11
14717480902368InnoClipDC5T1-BX2023-07-11
14717480902375InnoClipDC5T1-B62023-07-11
04717480900008Inno-PortDT501-7B2023-06-07
04717480900015Inno-PortDT501-7Q2023-06-07
04717480900022Inno-PortDT501-XB2023-06-07
04717480900039Inno-PortDT501-XQ2023-06-07
04717480900046Inno-PortDT501-7L2023-06-07
04717480900053Inno-PortDT501-7P2023-06-07
04717480900060Inno-PortDT501-XL2023-06-07
04717480900077Inno-PortDT501-XP2023-06-07
04717480900084Inno-PortDT501-712023-06-07
04717480900121Inno-PortDTW01-XB2023-06-07
04717480900138Inno-PortDTW01-XQ2023-06-07

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20653405037108REFLEXConmed CorporationGDT2020-11-21
50885632126244MediChoiceOWENS & MINOR DISTRIBUTION, INC.GDT2020-10-08