AccessGUDID - DEVICE: 3M™ (04035077006774)

GUDID

Device Identifier (DI) Information

Brand Name: 3M™
Version or Model: 56943
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 56943
Company Name: 3M Deutschland GmbH

Primary DI Number: 04035077006774
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 315731711 *Terms of Use

Device Description: 3M™ ESPE™ Astringent Retraction Paste Sample Pack, 56943

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:	Yes
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?
16352	Gingival retraction kit	A collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVL	CORD, RETRACTION

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 02133dd8-bba0-4d74-9401-8692021fb6e8
Public Version Date: April 02, 2018
Public Version Number: 1
DI Record Publish Date: March 01, 2018

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: 04035077028370 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)634-2249
Email: 3Mhealthcarecompliance@mmm.com

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

FDA TOOLS & RESOURCES