FDA.reportPublic FDA data

Single Use Circular Stapler

Primary DI
16946912215013
Brand
Single Use Circular Stapler
Company
Golden Stapler Surgical Co.,Ltd
Model
CSA21
Published
2019-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162707000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162707000Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and ReloadGolden Stapler Surgical Co., Ltd.2017-07-14GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16946912215013PackageGS16In Commercial Distribution
06946912215016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694691221501316946912215013
06946912215016069469122150166946912215016

GMDN Terms#

Term, Definition table
TermDefinition
Intraluminal circular stapler, single-useA sterile, hand-held, manual surgical instrument intended to be used during open or laparoscopic surgical procedures of the alimentary tract, to create anastomoses (e.g., end-to-end, end-to-side, or side-to-side) via intraluminal (within the lumen) resection. It is designed to connect two portions of lumen (e.g., colon) with a single or multiple circular rows of staples, and then cut out the tissue within the staple line to create a new channel. This device operates via a manual lever mechanism and may be available in a variety of sizes appropriate to a specific luminal diameter. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527606074
Device count
1
DM exempt
false
Premarket exempt
false
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
06946912216044Single Use Circular StaplerCSB292019-06-14
06946912216051Single Use Circular StaplerCSB322019-06-14
06946912216068Single Use Circular StaplerCSB342019-06-14
06946912217010Single Use Circular StaplerCSC212019-06-14
06946912217027Single Use Circular StaplerCSC232019-06-14
06946912217034Single Use Circular StaplerCSC262019-06-14
06946912217041Single Use Circular StaplerCSC292019-06-14
06946912217058Single Use Circular StaplerCSC322019-06-14
06946912217065Single Use Circular StaplerCSC342019-06-14
16946912216041Single Use Circular StaplerCSB292019-06-14
16946912216058Single Use Circular StaplerCSB322019-06-14
16946912216065Single Use Circular StaplerCSB342019-06-14
16946912217017Single Use Circular StaplerCSC212019-06-14
16946912217024Single Use Circular StaplerCSC232019-06-14
16946912217031Single Use Circular StaplerCSC262019-06-14
16946912217048Single Use Circular StaplerCSC292019-06-14
16946912217055Single Use Circular StaplerCSC322019-06-14
16946912217062Single Use Circular StaplerCSC342019-06-14
06946912215016Single Use Circular StaplerCSA212019-06-13
06946912215023Single Use Circular StaplerCSA232019-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521703827Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703858Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703797Tri-Staple 2.0Covidien LPGDW2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGDW2026-07-31
16953886000033TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000040TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000057TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000064TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000071TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000088TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000095TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000101TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000330TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000347TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000354TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000408TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000415TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000422TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000439TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000446TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000453TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000460TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000477TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000484TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000491TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000514TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000521TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000569TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27