AccessGUDID - DEVICE: EXMOOR (05060180252106)

GUDID

Device Identifier (DI) Information

Brand Name: EXMOOR
Version or Model: SRS.6a(29)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SRS6A(29)
Company Name: EXMOOR PLASTICS LIMITED

Primary DI Number: 05060180252106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 298725490 *Terms of Use

Device Description: Silicone rubber sheet

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):	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?
45231	Silicone-sheet tissue reconstructive material, non-sterile	A non-sterile, flat stretch of silicone elastomer typically modified to suit the patient anatomy intended to be implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile). It may be cut into different sizes and shapes for various reconstructive or cosmetic plastic surgery applications that include repair of nasal septums, perforated eardrums, herniations, diaphragms, orbital floors, or congenital fissures of the abdominal wall.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K911503	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: Keep out of direct sunlight.
Special Storage Condition, Specify: Store in a dry environment. Avoid extremes of temperature and humidity.
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5620bcda-a2f1-49a7-84ba-75581813363a
Public Version Date: February 19, 2024
Public Version Number: 3
DI Record Publish Date: September 21, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05060180254612	20	05060180252106		In Commercial Distribution	a 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +441823351040
Email: sales@exmoorltd.com

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