AccessGUDID - DEVICE: Corning® (H10820281)

GUDID

Device Identifier (DI) Information

Brand Name: Corning®
Version or Model: 2028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2028
Company Name: Corning Incorporated

Primary DI Number: H10820281
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 001307735 *Terms of Use

Device Description: VIAL,2.0ML,RB,SS,INT,ORANGE CAP,PP,S,BK,50/250

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?
44904	Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMH	CONTAINER, SPECIMEN, STERILE

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: 5af3554b-6f54-4e46-aeae-9608b383edb4
Public Version Date: June 17, 2022
Public Version Number: 3
DI Record Publish Date: December 02, 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
H10820283	5	H10820281		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: H10820280 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)492-1110
Email: scientificsupport@corning.com

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