AccessGUDID - DEVICE: Bioseal Inc. (00630094173405)

GUDID

Device Identifier (DI) Information

Brand Name: Bioseal Inc.
Version or Model: 17340/50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOSEAL

Primary DI Number: 00630094173405
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 186968939 *Terms of Use

Device Description: Glass Medicine Dropper

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):	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?
37454	Ear dropper, single-use	A device intended to be used for aspirating a small volume of liquid so that it can be dispensed in single drops into the ear canal. It is typically designed as a hollow tube, open at both ends, with an aspiration bulb attached to the proximal and a narrow opening at the distal end. It is usually made of glass or plastic with a rubber teat and may be used in conjuction with ear/nose/throat (ENT) treatments. It may contain a medication. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYW	CONTAINER, LIQUID MEDICATION, GRADUATED

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: Yes
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: 1d67c413-9d08-4b3f-b0b9-7d183c5a4044
Public Version Date: September 26, 2023
Public Version Number: 1
DI Record Publish Date: September 18, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10630094173402	50	00630094173405		In Commercial Distribution	Case

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: Yes
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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