AccessGUDID - DEVICE: REYNOLDS TENOTOMY SCISSORS (00192896063945)

GUDID

Device Identifier (DI) Information

Brand Name: REYNOLDS TENOTOMY SCISSORS
Version or Model: 2400-326
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2400-326
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896063945
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: REYNOLDS TENOTOMY SCISSORS STRAIGHT BLADES POWER CUT GOLD

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":	No
For Single-Use:	No
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?
13999	Tenotome	A small, narrow-bladed knife mounted on a slender handle; usually used to cut a tendon. This GMDN code is sometimes applied to fine scissors, often adapted with a spring-like mechanism to keep the scissors open, used to cut tendons. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRR	SCISSORS, ORTHOPEDIC, SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 6.25 Inch

Device Record Status

Public Device Record Key: e39dbc6a-b0bc-4ae3-92f0-2f270d5ef726
Public Version Date: November 05, 2018
Public Version Number: 1
DI Record Publish Date: October 03, 2018