AccessGUDID - DEVICE: MARTIN LEWIS G.C. SYSTEM (M2027657ML2)

GUDID

Device Identifier (DI) Information

Brand Name: MARTIN LEWIS G.C. SYSTEM
Version or Model: 7-657-ML
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7-657-ML
Company Name: Healthlink

Primary DI Number: M2027657ML2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 079376107 *Terms of Use

Device Description: MARTIN LEWIS G.C. SYSTEM

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):	Yes
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?
58646	Neiserria species agar culture medium IVD, basic	A selective and/or differential agar culture medium intended to be used for the growth and isolation of Neisseria gonorrhoea and/or other Neisseria species from a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JTY	CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K950196	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 100 Millimeter
Device Size Text, specify: 100 mm

Device Record Status

Public Device Record Key: 9a1d884b-91b2-4af6-ad69-502c949160e7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M2027657ML3	12	M2027657ML2		In Commercial Distribution	Box

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: M2027657ML0 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)638-2625
Email: HLKCustomerSvc@clorox.com

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