AccessGUDID - DEVICE: DELTA (07613252444237)

GUDID

Device Identifier (DI) Information

Brand Name: DELTA
Version or Model: 70-92004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-92004
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613252444237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: Delta 1.7mm Plate 2x21 holes x 0.5mm

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Craniofacial fixation plate, bioabsorbable	A small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

GMDN Preferred Term Name

GMDN Definition

Craniofacial fixation plate, bioabsorbable

A small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

FDA Product Code

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Product Code	Product Code Name
MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

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

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Storage and Handling
Storage Environment Temperature: less than 49 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Thickness: 0.5 Millimeter
Device Size Text, specify: 3D Plates: 2x21 Holes

Device Record Status

Public Device Record Key: 6cd859c2-6501-40d9-9ab5-a6623c19210f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2015