AccessGUDID - DEVICE: ACE (00614950021864)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 0531008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0531008
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950021864
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: JAR NEEDLE OR OINTMENT STAINLESS STEEL 3"X2-1/2"

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?
10171	Applicator jar	A cylindrical vessel designed for holding various types of applicators (e.g., swabs, towelettes) in a clean container to reduce the possibility of contamination and to be ready for use. It is typically made of high-grade stainless steel, glass, or less frequently sterilizable plastic material (e.g., polypropylene). It will have a wide or weighted base to give it stability and a tightly sealed cover (lid). It is frequently used in ear/nose/throat (ENT) procedures, as well as procedures on the eyes, or the vagina and used in, e.g., an examination room, a doctor's surgery, or the sterile field during a surgical intervention. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: No special storage conditions required

Clinically Relevant Size

[?]

Size Type Text
Length: 3 Inch

Device Record Status

Public Device Record Key: 1ea4d72c-9d51-4dd4-a2f5-428233b96f6b
Public Version Date: October 28, 2019
Public Version Number: 1
DI Record Publish Date: October 19, 2019