AccessGUDID - DEVICE: Typenex Medical Inoculation Loop (00810050854993)

GUDID

Device Identifier (DI) Information

Brand Name: Typenex Medical Inoculation Loop
Version or Model: LP0201
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TYPENEX MEDICAL LLC

Primary DI Number: 00810050854993
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600850213 *Terms of Use

Device Description: Inoculation Loop – 10uL

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":	Yes
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?
15155	Inoculating tool IVD, manual	A hand-held device intended to be used to transfer and spread inoculum from a clinical specimen and/or culture isolate into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It typically consists of a slender handle with an attached loop or swab on the proximal end to collect and transfer a specimen into the culture medium. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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
Total Volume: 10 Microliter

Device Record Status

Public Device Record Key: a9abeab2-c539-49e6-804a-75c0d6ec002a
Public Version Date: November 17, 2022
Public Version Number: 1
DI Record Publish Date: November 09, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10810050854990	10	00810050854993	In Commercial Distribution	Inner Bag
00810050855006	50	10810050854990	In Commercial Distribution	Case
10810050855003	6	00810050855006	In Commercial Distribution	Master Carton