FDA.reportPublic FDA data

TOUCHSTONE

Primary DI
16953886000330
Brand
TOUCHSTONE
Company
Touchstone International Medical Science Co., Ltd.
Model
PPHplus
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
GDWStaple, Implantable

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141097000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141097000CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USETouchstone International Medical Science Co., Ltd.2014-09-26GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16953886000330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1695388600033016953886000330

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.

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
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
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
16953886001429TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886001443TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886001450TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886001467TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886001474TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886001481TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886001498TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27