AccessGUDID - DEVICE: OPTICS ONE (00815384023213)

GUDID

Device Identifier (DI) Information

Brand Name: OPTICS ONE
Version or Model: MTI-2500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MTI-2500
Company Name: MEDICAL TECHNIQUE, INC.

Primary DI Number: 00815384023213
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790514756 *Terms of Use

Device Description: Armboard Straps 1 x 30

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":	Yes
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?
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
NZD	Stretcher, Patient Restraint

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: cbf85e43-a8b2-414b-99ac-a7ad3643b124
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00815384023220	10	00815384023213		In Commercial Distribution	INNER PACK

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 520-733-7999
Email: INFO@MTIDRAPE.COM

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