AccessGUDID - DEVICE: FOLLISTIM PEN STARTER KIT USA (00300520311540)

GUDID

Device Identifier (DI) Information

Brand Name: FOLLISTIM PEN STARTER KIT USA
Version or Model: 1022692
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Merck Sharp & Dohme LLC

Primary DI Number: 00300520311540
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 101740835 *Terms of Use

Device Description: No description.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
44127	Autoinjector needle	A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.	Active	false
45771	Empty self-injector, mechanical	A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. A dial on the injector is operated for dosing (e.g., via a spring-loaded mechanism). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSC	INJECTOR, PEN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Needle Gauge: 29 Gauge
Length: 6.25 Inch
Device Size Text, specify: needles
Device Size Text, specify: reusable pen injector

Device Record Status

Public Device Record Key: 6043ed5f-dc2e-4681-b433-49153ddc6af0
Public Version Date: April 03, 2024
Public Version Number: 5
DI Record Publish Date: November 14, 2019