FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040029077
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9007010
Catalog number
9007010
Device description
Stapler Skin Disposable
Published
2018-09-24
Public version status
New
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
GAGSTAPLER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040029074PackageGS15In Commercial Distribution
20304040029071PackageGS120In Commercial Distribution
00304040029077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404002907410304040029074
2030404002907120304040029071
00304040029077003040400290773040400290770304040029077

GMDN Terms#

Term, Definition table
TermDefinition
Skin staplerA sterile hand-held surgical instrument designed for the application of skin staples to approximate free edges of skin from an incision or wound. This device, often pistol-like in design, is typically loaded with staples and is intended to mechanically deliver staples with manual power. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.2Millimeter

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
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479282852McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282883McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282890McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282906McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282913McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282920McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282937McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282944McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283019McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283194McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283200McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283217McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283224McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283231McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283248McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283255McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284597McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284641McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284986McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285006McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285020McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285105McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
00190776409500MillenniumAvalign Technologies, Inc.GAG2025-09-02
10705036043522ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043539ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043546ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043529ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043536ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043543ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10888277368293MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAG2025-02-14