AccessGUDID - DEVICE: Reloading Unit for Endo Linear Cutter Stapler (06939282409864)

GUDID

Device Identifier (DI) Information

Brand Name: Reloading Unit for Endo Linear Cutter Stapler
Version or Model: CADA-30D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: B. J. ZH. F. Panther Medical Equipment Co., Ltd.

Primary DI Number: 06939282409864
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559966539 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59871	Endoscopic manual linear cutting stapler, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDW	Staple, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142577	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: be8602f3-554e-4431-8a0d-078895cfdb64
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: April 04, 2018