AccessGUDID - DEVICE: Burnshield (06007645001380)

GUDID

Device Identifier (DI) Information

Brand Name: Burnshield
Version or Model: 901111
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 901111
Company Name: BURNSHIELD (PTY) LTD

Primary DI Number: 06007645001380
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 635842958 *Terms of Use

Device Description: BURNSHIELD 10X10CM DRESSINGS IN BULK

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?
47693	Synthetic polymer burn dressing, gel-coated	A sterile covering designed to treat small to large patient burns. It is made from synthetic polymer material impregnated with wound gel (e.g., hydrogel) and is applied over the burn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is available in various sizes (e.g., 10x10 cm to 60x40 cm) and may be body contoured; it is also available in prefabricated shapes (e.g., face mask). It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K943728	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
Storage Environment Temperature: between -10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 40 Gram
Width: 100 Millimeter
Length: 100 Millimeter

Device Record Status

Public Device Record Key: 9bfcae76-17e4-4fd8-b566-3fdaa14385f4
Public Version Date: December 20, 2022
Public Version Number: 6
DI Record Publish Date: December 17, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
96007645001383	2	86007645001386	In Commercial Distribution	BOX
86007645001386	125	06007645001380	In Commercial Distribution	BOX
36007645001381	10	16007645001387	In Commercial Distribution	BOX
16007645001387	25	06007645001380	In Commercial Distribution	BOX
06007645004527	2	06007645001380	In Commercial Distribution	BOX
16007645004524	100	06007645004527	In Commercial Distribution	BOX
06007645000376	15	06007645001380	In Commercial Distribution	BOX
76007645001389	10	06007645000376	In Commercial Distribution	BOX
56007645001385	12	06007645000376	In Commercial Distribution	BOX
06007645009744	60	06007645001380	In Commercial Distribution	BOX
16007645009741	4	06007645009744	In Commercial Distribution	BOX

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: +27114405171
Email: sales@burnshield.com

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