FDA.reportPublic FDA data

Signet

Primary DI
10884521080669
Brand
Signet
Company
Covidien LP
Model
054006
Device description
Skin Stapler
Published
2018-08-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDTSTAPLE, REMOVABLE (SKIN)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDTStaple, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521080666PackageGS16Not in Commercial Distribution
10884521080669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452108066620884521080666
1088452108066910884521080669

GMDN Terms#

Term, Definition table
TermDefinition
Skin stapler/staple, non-bioabsorbableA hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24
10884521211933Shiley5-182372017-05-10
10884521543799SigniaSIGPSHELL2017-08-08
10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00661392055148LSL HEALTHCARELSL Industries, LLCGDT2025-10-30
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20197344111050MEDLINEMEDLINE INDUSTRIES, INC.GDT2025-03-05
10080196846924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
40080196846925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
00192896120228Michel Wound ClipsSONTEC INSTRUMENTS, INC.GDT2024-10-15
14026704741943WECKTELEFLEX INCORPORATEDGDT2024-07-17
24026704741940WECKTELEFLEX INCORPORATEDGDT2024-07-17
04717480900374Taiwan SurgicalTAIWAN SURGICAL CORPORATIONGDT2023-08-02
04719880180493Haritex CorporationHARITEX CORPORATIONGDT2023-06-19
10841767102944Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
00841767102947Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
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