AccessGUDID - DEVICE: Disposable Instruments (00845819001066)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Instruments
Version or Model: 4027A, B-4027A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OASIS MEDICAL, INC.

Primary DI Number: 00845819001066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 194121018 *Terms of Use

Device Description: Kratz Capsule Polisher 23g x 7/8” (0.64 x 22mm), 9mm Bend

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):	Yes
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?
47007	Ophthalmic surgical irrigation/infusion/aspiration handle, single-use	A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMX	Cannula, 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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation 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: 1fec6645-0bc1-4394-b8ff-f4c5e553e5d9
Public Version Date: July 10, 2023
Public Version Number: 1
DI Record Publish Date: June 30, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10845819001063	10	00845819001066		In Commercial Distribution	Carton
20845819001060	100	00845819001066		In Commercial Distribution	Plastic Bag

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 9093055400
Email: customerservice@oasismedical.com

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