AccessGUDID - DEVICE: Wolf X-Ray Protective Gloves (00843696131890)

GUDID

Device Identifier (DI) Information

Brand Name: Wolf X-Ray Protective Gloves
Version or Model: 12425
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Flow X Ray Corporation

Primary DI Number: 00843696131890
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010016319 *Terms of Use

Device Description: Superflex Protective Gloves with Flared Cuff, 15" 0.5mm LEV

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):	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?
38365	Radiation-shielding procedure preparation glove/mitten	A personal protective device intended to be used to shield the entire hand or hands of medical personnel from unnecessary exposure to primary and scattered radiation associated with the preparation of a diagnostic and/or therapeutic radiological procedure (e.g., patient positioning). It is typically intended for procedure set-up or patient positioning; it is not a patient examination/treatment glove, nor a surgical glove. It typically includes a thin layer of lead (Pb) or lead-equivalent material and may be fluid resistant.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWP	Radiographic Protective Glove

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: 0b771b55-1880-4bf4-84d1-2bd316c5c800
Public Version Date: June 28, 2023
Public Version Number: 2
DI Record Publish Date: August 03, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES