FDA.reportPublic FDA data

SM

Primary DI
20884521080734
Brand
SM
Company
Covidien LP
Model
050284
Catalog number
050284
Device description
Skin Stapler Reload
Published
2018-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
20884521080734PackageGS112In Commercial Distribution
10884521080737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452108073420884521080734
1088452108073710884521080737

GMDN Terms#

Term, Definition table
TermDefinition
Surgical staple loading unit, non-cuttingA unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.

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
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521091986NellcorSC-A-I2026-05-25
20884521841724Shiley50FXLTCP2026-03-17
20884521841687Shiley50FXLTCD2026-03-16
20884521841694Shiley60FXLTCD2026-03-16
20884521841700Shiley70FXLTCD2026-03-16
20884521841717Shiley80FXLTCD2026-03-16
20884521841731Shiley60FXLTCP2026-03-16
20884521841748Shiley70FXLTCP2026-03-16
20884521841755Shiley80FXLTCP2026-03-16
20884521841762Shiley50FXLTUD2026-03-16
20884521841779Shiley60FXLTUD2026-03-16
20884521841786Shiley70FXLTUD2026-03-16
20884521841793Shiley80FXLTUD2026-03-16
20884521841809Shiley50FXLTUP2026-03-16
20884521841816Shiley60FXLTUP2026-03-16
20884521841823Shiley70FXLTUP2026-03-16
20884521841830Shiley80FXLTUP2026-03-16
30884521841844Shiley50FXLTIN2026-03-16
20884521841854Shiley60FXLTIN2026-03-16
20884521841861Shiley70FXLTIN2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344111050MEDLINEMEDLINE INDUSTRIES, INC.GDT2025-03-05
40080196846925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
00192896120228Michel Wound ClipsSONTEC INSTRUMENTS, INC.GDT2024-10-15
24026704741940WECKTELEFLEX INCORPORATEDGDT2024-07-17
04717480900374Taiwan SurgicalTAIWAN SURGICAL CORPORATIONGDT2023-08-02
04719880180493Haritex CorporationHARITEX CORPORATIONGDT2023-06-19
00841767102947Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
00850018777025microMendKitotech Medical IncGDT2022-12-08
00850018777049microMend PROKitotech Medical IncGDT2022-12-08
00850018777117microMend PROKitotech Medical IncGDT2022-12-08
00850018777223microMendKitotech Medical IncGDT2022-12-08
00850018777261microMend Kitotech Medical IncGDT2022-12-08
00850018777278microMend PROKitotech Medical IncGDT2022-12-08
00850018777292microMend PROKitotech Medical IncGDT2022-12-08
00850018777001microMend PROKitotech Medical IncGDT2022-12-08
00850018777216microMend PROKitotech Medical IncGDT2022-12-08
00850018777094microMend PROKitotech Medical IncGDT2022-12-08
00850018777155microMend PROKitotech Medical IncGDT2022-12-08
00850018777179microMend PROKitotech Medical IncGDT2022-12-08
04719880180387NAHARITEX CORPORATIONGDT2022-12-07
04719880180394NAHARITEX CORPORATIONGDT2022-12-05
20801902192077ARROWTELEFLEX INCORPORATEDGDT2022-11-29
40195327227716Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2022-08-28
40195327234530Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2022-08-28
00840216104372ASP MEDICALAsp Global, LLCGDT2022-08-15
00840216104389ASP MEDICALAsp Global, LLCGDT2022-08-15
40888277071828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2022-08-04
00192896107472Michel Wound ClipsSONTEC INSTRUMENTS, INC.GDT2021-04-14
10850010207190BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.GDT2021-03-01
20653405037108REFLEXConmed CorporationGDT2020-11-21