AccessGUDID - DEVICE: MEDLINE INDUSTRIES (10884389024218)

GUDID

Device Identifier (DI) Information

Brand Name: MEDLINE INDUSTRIES
Version or Model: DYNJBW26
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DYNJBW26
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10884389024218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: WAX,BONE,SYNTHETIC

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":	Yes
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?
44811	Bone wax, synthetic	A sterile, implantable device in the form of a sterile wax-like, putty-like, or paste material designed to stop bone bleeding by the creation of a physical barrier along the edges of bone that has been damaged by trauma or cut during a surgical procedure. When placed on the bone under moderate pressure it plugs the vascular openings in the bone and prevents further bleeding. It is typically made from biocompatible/bioabsorbable synthetic substances (e.g., water-soluble copolymers); its stickiness may be increased by warming and by additional handling and manipulation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MTJ	Wax, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: between 21 and 23 Degrees Celsius
Special Storage Condition, Specify: Protect from freezing. Avoid excessive heat. Shield from direct sunlight. Keep Dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 22af4c2e-fbb7-4ed4-a64a-d02fb6fb8641
Public Version Date: May 02, 2024
Public Version Number: 1
DI Record Publish Date: April 24, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30884389024212	12	10884389024218		In Commercial Distribution	BX

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: +1(800)633-5463
Email: service@medline.com

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