AccessGUDID - DEVICE: N/A (00810047421955)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 452
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Scientific Device Laboratory, Inc.

Primary DI Number: 00810047421955
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 115927956 *Terms of Use

Device Description: E. coli Suspension [1cc vial - each]

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?
63319	General microbial isolate identification control IVD	A substance containing a viable microorganism intended to be used to verify the performance of an assay or culture medium used in microbial testing for the identification of a microorganism isolated from a clinical specimen; it is not specific to any particular microbial assay. The microbial strain is typically impregnated on a suitable material (e.g., paper), air-dried and fixed onto a slide, or freeze-dried into a pellet, and may include accessories (e.g., swab, inoculating fluid).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIB	Device, General Purpose, Microbiology, Diagnostic

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: a60234db-b369-43d0-b6a9-1fff9e82ccf2
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 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
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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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