AccessGUDID - DEVICE: ACE (00614950021895)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 0531013
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0531013
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950021895
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: JAR DRESSING 1/2QT STAINLESS STEEL 4-1/8"X3-1/4"

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
Height: 3.25 Inch

Device Record Status

Public Device Record Key: cd5b5401-5532-4ed9-948a-ae060040bb9e
Public Version Date: October 28, 2019
Public Version Number: 1
DI Record Publish Date: October 19, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)441-3100
Email: ritaknight@acesurgical.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES