FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040029084
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9007011
Catalog number
9007011
Device description
Remover Stapler Skin
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
10304040029081PackageGS120In Commercial Distribution
20304040029088PackageGS110In Commercial Distribution
00304040029084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404002908110304040029081
2030404002908820304040029088
00304040029084003040400290843040400290840304040029084

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length97Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00with no erosive gas
Storage Environment Humidity50 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040058084Henry Schein112673611267362019-11-26
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05

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
00850018777087microMend PROKitotech Medical IncGDT2022-12-08
00850018777100microMend PROKitotech Medical IncGDT2022-12-08
00850018777124microMend PROKitotech Medical IncGDT2022-12-08
00850018777162microMend PROKitotech Medical IncGDT2022-12-08
00850018777186microMend PROKitotech Medical IncGDT2022-12-08
00850018777285microMend PROKitotech Medical IncGDT2022-12-08
00850018777308microMend PROKitotech Medical IncGDT2022-12-08
00850018777315microMend PROKitotech Medical IncGDT2022-12-08
00850018777322microMend PROKitotech Medical IncGDT2022-12-08
00850018777339microMend PROKitotech Medical IncGDT2022-12-08
00850018777346microMend PROKitotech Medical IncGDT2022-12-08
00850018777360microMend PROKitotech Medical IncGDT2022-12-08
00850018777391microMend PROKitotech Medical IncGDT2022-12-08
00850018777025microMendKitotech Medical IncGDT2022-12-08
00850018777049microMend PROKitotech Medical IncGDT2022-12-08
00850018777117microMend PROKitotech Medical IncGDT2022-12-08
00850018777223microMendKitotech Medical IncGDT2022-12-08