AccessGUDID - DEVICE: SPATIAL FRAME (00885556057179)

GUDID

Device Identifier (DI) Information

Brand Name: SPATIAL FRAME
Version or Model: 71932388
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 71932388
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00885556057179
Issuing Agency: GS1
Commercial Distribution End Date: June 09, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: SPATIAL FRAME U PLATE 105MM ID W/ EXTRA HOLES

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?
48011	External orthopaedic fixation system, single-use	An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDW	PIN, FIXATION, THREADED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K994143	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
No Device Sizes

Device Record Status

Public Device Record Key: 45cb713e-5563-4955-839c-fca0a7286438
Public Version Date: September 07, 2023
Public Version Number: 6
DI Record Publish Date: August 29, 2015