AccessGUDID - DEVICE: BOEHRINGER® Arm Restraint Straps ( 1 pair )

GUDID

Device Identifier (DI) Information

Brand Name: BOEHRINGER® Arm Restraint Straps ( 1 pair ) - 27 Inches
Version or Model: 9008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9008
Company Name: BOEHRINGER LABORATORIES, LLC

Primary DI Number: 10816286020567
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079991657 *Terms of Use

Device Description: Arm Restraint Straps ( 1 pair ) - 27 Inches

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:	No
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?
35304	Arm restraint	A non-rigid device, typically a strap or band made of various materials (e.g., fabric, nylon, leather, foam), used to temporarily secure a patient's arm(s) to a fixture or furniture part (e.g., bedrail, chair, table leg) to restrict the patient's physical activity for the prevention of potential injury or hazards. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FMQ	Restraint, Protective

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: 9fb32c66-6ca7-46b4-9462-ccd6061d4651
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 01, 2016