AccessGUDID - DEVICE: CUSTOMED (M20890030527)

GUDID

Device Identifier (DI) Information

Brand Name: CUSTOMED
Version or Model: 712057693052
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9003052
Company Name: CUSTOMED INC

Primary DI Number: M20890030527
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 627572217 *Terms of Use

Device Description: CUSTOMFEEL LATEX POWDERED SURGICAL GLOVE 8.5

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):	No
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?
47179	Hevea-latex surgical glove, powdered	A sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is covered with talcum powder primarily to facilitate donning and removal; it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGO	Surgeon'S Gloves

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010198	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Avoid Ozone.
Special Storage Condition, Specify: Store in Cool Dry Place.

Clinically Relevant Size

[?]

Size Type Text
Circumference: 8.5 Inch

Device Record Status

Public Device Record Key: 00d1dd66-b001-4a93-97ef-3ea0bd8951fd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 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
M20890030521	50	M20890030527		In Commercial Distribution	50PR/BOX
M20890030522	5	M20890030521		In Commercial Distribution	50PR/BOX, 5BOX/CS

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: M20890030520 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: 787-622-5151
Email: customer.service@customedhealing.com

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