AccessGUDID - DEVICE: Henry Schein (10304040029470)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 1126716
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1126716
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 10304040029470
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Retreat Knitted Cord w/Epi

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:	Yes
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?
16195	Dental matrix band, reusable	A band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable 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: 1588c567-e7bc-46c2-ad8d-c2239b560647
Public Version Date: April 29, 2020
Public Version Number: 1
DI Record Publish Date: April 21, 2020

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: 00304040029473 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

[?]

No Customer Contact currently defined

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