AccessGUDID - DEVICE: Sterling Medical Products (00685404002715)

GUDID

Device Identifier (DI) Information

Brand Name: Sterling Medical Products
Version or Model: IN9009S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APOLLO MEDICAL PRODUCTS CORP.

Primary DI Number: 00685404002715
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116768422 *Terms of Use

Device Description: ROPE AND HOOK WITH "S" HOOK

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?
62664	Traction cord	A length of synthetic fibre (e.g., nylon) intended to be used with a system of rope and pulleys, or a bed traction system, to apply traction forces during medical procedures (e.g., orthopaedic surgery, physical therapy). It is typically intended to be cut to the desired length, threaded around pulleys, and knotted where needed. This is a reusable 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: 3407ba9e-254a-47ab-b7d9-6d56207358f1
Public Version Date: October 02, 2023
Public Version Number: 1
DI Record Publish Date: September 23, 2023