AccessGUDID - DEVICE: Biopsy Forceps

GUDID

Device Identifier (DI) Information

Brand Name: Biopsy Forceps - Hot
Version or Model: SG-111-615H
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SG-111-615H
Company Name: ENDO-THERAPEUTICS, INC.

Primary DI Number: 00816207020570
Issuing Agency: GS1
Commercial Distribution End Date: November 04, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 825239189 *Terms of Use

Device Description: Electrosurgical endoscopic biopsy forceps

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K800973	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Min Channel 2.8 mm
Outer Diameter: 2.4 Millimeter
Length: 160 Centimeter

Device Record Status

Public Device Record Key: 11342cb8-b128-40d1-9381-cfc5d51d458a
Public Version Date: November 05, 2019
Public Version Number: 4
DI Record Publish Date: September 20, 2016