AccessGUDID - DEVICE: Henry Schein (00304040115305)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 9006047
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9006047
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040115305
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Cotton Roll dispenser

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):	Yes
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?
64506	Dressing dispenser	A freestanding container with an opening designed to hold and dispense dressings (including swabs and bandages) in discrete quantities (e.g., one at a time) at the point of use. It is typically a plastic or metal container with a lid to allow loading of the dressings, and a separate port to allow easy retrieval of the dressings. It is used in settings such as an examination room, a doctor's surgery, or where surgical procedures are performed in the hospital. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKX	AID, TRANSFER

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: 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: cea1ca4e-66f3-442e-889f-262df841194b
Public Version Date: January 14, 2020
Public Version Number: 1
DI Record Publish Date: January 06, 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: 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: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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