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
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09
10884521837126ILLUMISITEILS-1000-CS2024-08-09
10884521837133ILLUMISITEILS-1000-CS2024-08-09
10884521837140ILLUMISITEILS-1000-CS2024-08-09
10884521837157ILLUMISITEILS-1000-CS2024-08-09
10884521842915ILLUMISITEILS-1000-CS2024-08-09
10884521837096ILLUMISITEILS-1000-CS2023-09-17
10884521199996superDimensionAAS00161-20RAAS00161-20R2016-09-24
10884521747425superDimensionPMB00667-012018-02-28
10884521747432superDimensionPMB00569-012018-02-28
10884521199989superDimensionAAS00161-202016-09-24
10884521747418superDimensionILS-0001-FN2018-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118602150Endure IndustriesENDURE INDUSTRIESGDT2026-08-14
00661392055148LSL HEALTHCARELSL Industries, LLCGDT2025-10-30
10197344111053MEDLINEMEDLINE INDUSTRIES, INC.GDT2025-03-05
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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00850018777049microMend PROKitotech Medical IncGDT2022-12-08
00850018777117microMend PROKitotech Medical IncGDT2022-12-08
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