FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040057100
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5700620
Catalog number
5700620
Device description
Skin Staple Remover with Gauze Sponge
Published
2017-07-13
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
HBSINSTRUMENT, CLIP FORMING/CUTTING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBSInstrument, Clip Forming/CuttingNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040057107PackageGS148In Commercial Distribution
00304040057100PrimaryGS10
20304040057104Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404005710710304040057107
00304040057100003040400571003040400571000304040057100
2030404005710420304040057104

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
012430880
Device count
48
Combination product
true
Lot or batch
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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233010437BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
00849233010444BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
00849233010635Busse Hospital DisposablesROBERT BUSSE & CO., INC.HBS2023-12-15
30849233010438BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
10849233010441BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
10849233010632Busse Hospital DisposablesROBERT BUSSE & CO., INC.HBS2023-12-15
07899893233069NEONAILNeoortho Produtos Ortopédicos S/A.HBS2023-10-31
07899893262038NEONAILNeoortho Produtos Ortopédicos S/A.HBS2023-10-27
08903993392645EXPERT TIBIA NAILAuxein Medical Private LimitedHBS2020-10-21
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07540194008688SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
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07540194008701SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008718SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008725SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008732SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008749SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008756SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008763SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008770SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12