AccessGUDID - DEVICE: Ambler Value Line (00190660215491)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Value Line
Version or Model: Knapp strabismus scissors
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 178-670
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660215491
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Knapp strabismus scissors, 4 1/2'', straight 25.0mm blades, blunt tips, ring handle

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?
63555	Intraocular scissors probe-tip, reusable	A distal component of a probe-like intraocular scissors assembly intended to be used to cut intraocular tissue (e.g., during anterior chamber surgery, vitrectomy). It is a probe-/cannula-like shaft with two shearing blades at the end, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). It is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNF	SCISSORS, OPHTHALMIC

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: 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: 77ca73fb-bfa4-4a79-ab45-a95c912151a9
Public Version Date: January 15, 2021
Public Version Number: 1
DI Record Publish Date: January 07, 2021