FDA.reportPublic FDA data

TOUCHSTONE

Primary DI
16953886000583
Brand
TOUCHSTONE
Company
Touchstone International Medical Science Co., Ltd.
Model
ELC-TS
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAGStapler, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141367000LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADSTouchstone International Medical Science Co., Ltd.2014-07-25GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16953886000583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1695388600058316953886000583

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic manual linear cutting stapler, single-useA sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecologic, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

Regulatory Flags#

DUNS number
547939608
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
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
16953886000033TOUCHSTONECSC212026-07-27
16953886000040TOUCHSTONECSC252026-07-27
16953886000057TOUCHSTONECSC292026-07-27
16953886000064TOUCHSTONECSC332026-07-27
16953886000071TOUCHSTONECSC21-A2026-07-27
16953886000088TOUCHSTONECSC25-A2026-07-27
16953886000095TOUCHSTONECSC29-A2026-07-27
16953886000101TOUCHSTONECSC33-A2026-07-27
16953886000118TOUCHSTONELC100382026-07-27
16953886000125TOUCHSTONELC60382026-07-27
16953886000132TOUCHSTONELC60452026-07-27
16953886000149TOUCHSTONELC80382026-07-27
16953886000156TOUCHSTONELC80422026-07-27
16953886000163TOUCHSTONELC80452026-07-27
16953886000170TOUCHSTONELCC100382026-07-27
16953886000187TOUCHSTONELCC60382026-07-27
16953886000194TOUCHSTONELCC60452026-07-27
16953886000200TOUCHSTONELCC80382026-07-27
16953886000217TOUCHSTONELCC80422026-07-27
16953886000224TOUCHSTONELCC80452026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16953886000118TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000125TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000132TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000149TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000156TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000163TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000170TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000187TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000194TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000200TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000217TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000224TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000231TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000248TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000255TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000262TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000279TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000286TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000293TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000309TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000316TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000323TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000361TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000378TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000538TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000545TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000576TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000590TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000606TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000613TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27