AccessGUDID - DEVICE: StripRight (B145113880)

GUDID

Device Identifier (DI) Information

Brand Name: StripRight
Version or Model: 11388
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OPTICAL INTEGRITY INC

Primary DI Number: B145113880
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024050887 *Terms of Use

Device Description: 550 µm StripRight Fiber Strip and Scribe Tool

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?
48018	Laser fibre stripper	A non-sterile, hand-held device used by authorized medical personnel to strip the outer protective layer (i.e., casing, jacket or buffer) from the end of a laser fibreoptic device without damaging the fibreoptics so that the bared end can be prepared for the next procedure (e.g, cleaving and repair). It is available in various designs and configurations, e.g., in the form of an electrical cable stripper (a pliers-like device) with two blades that hinge at a proximal end which are clamped over the fibreoptic device to be stripped and a mechanically adjustable depth limiter. It is configured to accept and strip one size or type of fibreoptic.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRT	STRIPPER, SURGICAL

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 37 Degrees Celsius
Special Storage Condition, Specify: store at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3bb01190-4965-4917-ae19-fc463a70f7c5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 03, 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
B145114891	5	B145113880		In Commercial Distribution	box

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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(850)233-5512
Email: customercare@opticalintegrity.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES