AccessGUDID - DEVICE: Britedent (D974BSI01011)

GUDID

Device Identifier (DI) Information

Brand Name: Britedent
Version or Model: BSI-0101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bright Supply, Inc.

Primary DI Number: D974BSI01011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124117012 *Terms of Use

Device Description: Barrier Film Blue

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
47082	Medical equipment/instrument drape dispenser	A device intended to be used to dispense sterile packs of instrument/equipment drapes that are normally sterile and used as a protective covering for various surgical and/or non-surgical instruments/equipment [e.g., a surgical or endoscopic tray, an operating room (OR) equipment table, an endoscope and endoscopic instruments]. This device typically holds a stack of drape/liner packs that are placed flat, one on top of the other, so that a user can remove a pack when required. This device is typically wall-mounted and can be made of metal and/or plastic materials.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWX	Barrier, Control Panel, X-Ray, Movable

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: b9c77e58-15e1-440b-8aed-4bf3bd21318d
Public Version Date: September 11, 2024
Public Version Number: 2
DI Record Publish Date: November 26, 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
D974BSI01012	8	D974BSI01011		In Commercial Distribution	Box

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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