DEVICE: Biopsy Forceps - Hot (00816207020570)

Device Identifier (DI) Information

Biopsy Forceps - Hot
SG-111-615H
In Commercial Distribution
SG-111-615H
ENDO-THERAPEUTICS, INC.
00816207020570
GS1

1
825239189 *Terms of Use
Electrosurgical endoscopic biopsy forceps
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry
CLOSE

Clinically Relevant Size

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

Device Record Status

11342cb8-b128-40d1-9381-cfc5d51d458a
March 29, 2018
2
September 20, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10816207020577 10 00816207020570 In Commercial Distribution box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
844-400-3636
customerservice@endotherapeutics.com
CLOSE