AccessGUDID - DEVICE: Specialist® (04042809231748)

GUDID

Device Identifier (DI) Information

Brand Name: Specialist®
Version or Model: 72345-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72345-02
Company Name: BSN MEDICAL, INC.

Primary DI Number: 04042809231748
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 026301221 *Terms of Use

Device Description: SPECIALIST STERILE COTTON PADDING 10CM X 3.6M NATURAL 25

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):	No
Over the Counter (OTC):	Yes
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?
58233	Cotton wool roll, sterile	A device designed as an absorbent, sterile mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector; it is not in the form of a bandage or dedicated dressing. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ITG	BANDAGE, CAST

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 360 Centimeter
Width: 10 Centimeter

Device Record Status

Public Device Record Key: 9f42d3d0-b48e-4489-8586-3f1ab5601183
Public Version Date: December 06, 2022
Public Version Number: 2
DI Record Publish Date: September 27, 2022

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: 04042809667271 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: +1(800)537-1063
Email: HMS.ORDERS@ESSITY.COM

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

FDA TOOLS & RESOURCES