FDA.reportPublic FDA data

Disposable Linear Cutter Staplers and Reloads

Primary DI
06946480576052
Brand
Disposable Linear Cutter Staplers and Reloads
Company
Sinolinks Medical Innovation Co., Ltd.
Model
DLC B-80B
Published
2025-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K131511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131511000DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORRChangzhou Sinolinks Medical Innovation Co., Ltd.2013-07-05GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946480576052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946480576052069464805760526946480576052

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery manual linear cutting stapler, single-useA sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528192598
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946480584057Disposable Skin Staplers DSSA-35-R2026-05-13
06946480584217Disposable Skin Staple Removers SRR2026-05-13
06946480584026Disposable Skin Staplers DSSA-15-W2026-03-13
06946480584040Disposable Skin Staplers DSSA-25-W2026-03-13
06946480584118Disposable Skin Staplers DSSB-15-R2026-03-13
06946480584125Disposable Skin Staplers DSSB-15-W2026-03-13
06946480584132Disposable Skin Staplers DSSB-25-R2026-03-13
06946480584149Disposable Skin Staplers DSSB-25-W2026-03-13
06946480584156Disposable Skin Staplers DSSB-35-R2026-03-13
06946480501276Disposable Circular StaplersDCS A-272025-09-04
06946480503638Disposable Linear Staplers and Reloads DLS B-60B2025-09-04
06946480510537Disposable Curved Cutter Staplers DCC B-40G2025-09-04
06946480563632Disposable Linear Staplers and ReloadsDLR 60-B2025-09-04
06946480576151Disposable Linear Cutter Staplers and Reloads DCR B-80B2025-09-04
06946480584064Disposable Skin Staplers DSSA-35-W2025-09-04
06946480584163Disposable Skin Staplers DSSB-35-W2025-09-04
06946480584224Disposable Skin Staple Removers SRW2025-09-04
06946480589311Disposable Endoscopic Linear Cutter Staplers and Reloads DEC-B 602025-09-04
06946480589366Disposable Endoscopic Linear Cutter Staplers and Reloads DER B 60T2025-09-04
06946480589373Disposable Endoscopic Linear Cutter Staplers and Reloads DER B 60P2025-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255200005MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200012MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200029MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909590MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909606MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909613MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909620MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909637MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909644MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909941MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909958MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909965MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909972MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909989MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
10705036040798ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040811ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040828ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040859ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036027850Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027867Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027874Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027881Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027898Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027904Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036030874Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036030881Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036030898Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
M06760001020Integrity Implant Fixation KitAnika Therapeutics, Inc.GDW2023-11-14
10705036022916N/AETHICON ENDO-SURGERY, LLCGDW2022-01-20
10705036022923N/AETHICON ENDO-SURGERY, LLCGDW2022-01-20