AccessGUDID - DEVICE: Sterling Medical Products (00685404001640)

GUDID

Device Identifier (DI) Information

Brand Name: Sterling Medical Products
Version or Model: 8119
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APOLLO MEDICAL PRODUCTS CORP.

Primary DI Number: 00685404001640
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116768422 *Terms of Use

Device Description: HORMONE PELLET 4.5MM TROCAR KIT

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:	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?
63148	Pellet implantation cannula, single-use	A rigid tube intended for subcutaneous delivery of an implantable drug pellet. The cannula is typically designed with a proximal well/side-hole for pellet loading, and typically includes a trocar blade to assist cannula introduction and a push rod to drive the pellet down the cannula; the implant is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No Device Sizes

Device Record Status

Public Device Record Key: 04e3fa52-2eec-44f3-adab-e2085383799d
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: September 27, 2019