FDA.reportPublic FDA data

Reloading Unit for Endo Linear Cutter Stapler

Primary DI
06939282409611
Brand
Reloading Unit for Endo Linear Cutter Stapler
Company
B. J. ZH. F. Panther Medical Equipment Co., Ltd.
Model
CADB-30N
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142577000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142577000PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.2015-06-11GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06939282409611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06939282409611069392824096116939282409611

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.

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
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
06939282409741Reloading Unit for Endo Linear Cutter StaplerCADB-45R2018-04-04

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
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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
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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