FDA.reportPublic FDA data

Circular Stapler

Primary DI
06939282448740
Brand
Circular Stapler
Company
B. J. ZH. F. Panther Medical Equipment Co., Ltd.
Model
FCSME34
Published
2018-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06939282448740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06939282448740069392824487406939282448740

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
Ethylene Oxide

Regulatory Flags#

DUNS number
559966539
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06939282408867Endo Linear Cutter Stapler CEAA-302018-04-04
06939282408874Endo Linear Cutter Stapler CEAA-452018-04-04
06939282408881Endo Linear Cutter Stapler CEAA-602018-04-04
06939282408898Endo Linear Cutter Stapler CEAB-302018-04-04
06939282408904Endo Linear Cutter Stapler CEAB-452018-04-04
06939282408911Endo Linear Cutter Stapler CEAB-602018-04-04
06939282409604Reloading Unit for Endo Linear Cutter StaplerCADB-30T2018-04-04
06939282409611Reloading Unit for Endo Linear Cutter StaplerCADB-30N2018-04-04
06939282409628Reloading Unit for Endo Linear Cutter StaplerCADB-30S2018-04-04
06939282409635Reloading Unit for Endo Linear Cutter StaplerCADB-30D2018-04-04
06939282409642Reloading Unit for Endo Linear Cutter StaplerCADB-45T2018-04-04
06939282409659Reloading Unit for Endo Linear Cutter StaplerCADB-45N2018-04-04
06939282409666Reloading Unit for Endo Linear Cutter StaplerCADB-45S2018-04-04
06939282409673Reloading Unit for Endo Linear Cutter StaplerCADB-45D2018-04-04
06939282409680Reloading Unit for Endo Linear Cutter StaplerCADB-60T2018-04-04
06939282409697Reloading Unit for Endo Linear Cutter StaplerCADB-60N2018-04-04
06939282409703Reloading Unit for Endo Linear Cutter StaplerCADB-60S2018-04-04
06939282409710Reloading Unit for Endo Linear Cutter StaplerCADB-60D2018-04-04
06939282409727Reloading Unit for Endo Linear Cutter StaplerCADA-45R2018-04-04
06939282409734Reloading Unit for Endo Linear Cutter StaplerCADA-60R2018-04-04

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
10884521845480SigniaCovidien LPGDW2024-11-29
10884521845497SigniaCovidien LPGDW2024-11-29
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