AccessGUDID - DEVICE: Midway Select (00843717108528)

GUDID

Device Identifier (DI) Information

Brand Name: Midway Select
Version or Model: 002-0627
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MIDWAY DENTAL SUPPLY, LLC

Primary DI Number: 00843717108528
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102354446 *Terms of Use

Device Description: Dental Dam Punch - Ainsworth Type

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):	No
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?
35553	Rubber dam punch	A hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIE	Dam, Rubber

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f20c9c0c-933b-435f-9772-194b70884a1f
Public Version Date: August 01, 2022
Public Version Number: 1
DI Record Publish Date: July 22, 2022

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: No
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

[?]

No Customer Contact currently defined

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