AccessGUDID - DEVICE: ACE (00614950025497)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 0031967
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0031967
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950025497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: CALCULATOR FOR X-RAY L/F MAGNIFICATION

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?
44262	Stationary panoramic dental x-ray system, analogue	A diagnostic analogue dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams to produce panoramic (wide field of view) images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware or software components. The image is from film or phosphor plate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTY	TAPE, MEASURING, RULERS AND CALIPERS

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
No Device Sizes

Device Record Status

Public Device Record Key: 801322df-5bcd-41f0-8ef1-2f8cbc8cd878
Public Version Date: November 01, 2019
Public Version Number: 1
DI Record Publish Date: October 24, 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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)588-3100 ext: 214
Email: ritaknight@acesurgical.com

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