AccessGUDID - DEVICE: Integra® Proximal Humeral Fracture Plate System (10381780120872)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Proximal Humeral Fracture Plate System
Version or Model: HFP0930106LS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HFP0930106LS
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780120872
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate implant. The plate is made from stainless steel. The low profile humeral fracture plate is designed to sit lower on the greater tuberosity and is available in six-hole.

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:	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?
61573	Orthopaedic fixation plate, non-bioabsorbable, non-sterile	A non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HRS	PLATE, FIXATION, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121826	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 4.405 mm L

Device Record Status

Public Device Record Key: 3117a2c8-f5b6-4a28-a3f8-4206fd155baf
Public Version Date: February 19, 2024
Public Version Number: 6
DI Record Publish Date: October 09, 2017