AccessGUDID - DEVICE: Reloading Unit for Linear Stapler (06939282439175)

GUDID

Device Identifier (DI) Information

Brand Name: Reloading Unit for Linear Stapler
Version or Model: (FLSL)H3.5E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: B. J. ZH. F. Panther Medical Equipment Co., Ltd.

Primary DI Number: 06939282439175
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?
59873	Open-surgery manual linear stapler, single-use	A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue; it has no cutting function. The staples 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 [?]
Premarket Submission Number Not Available/Not Released

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: c67e0f5e-94d8-43ad-9813-5248b85eb49a
Public Version Date: May 07, 2018
Public Version Number: 1
DI Record Publish Date: April 04, 2018