AccessGUDID - DEVICE: SyntheCel (10887587076669)

GUDID

Device Identifier (DI) Information

Brand Name: SyntheCel
Version or Model: SC.400.280.01S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SC40028001S
Company Name: Synthes GmbH

Primary DI Number: 10887587076669
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: SYNTHECEL® DURA REPAIR 14CM X 20CM (5.5"X 8") STER

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
48044	Dura mater graft, bioengineered	A sterile device made from bioengineered materials (e.g., cellulose fibres produced by microorganisms) used for the repair or replacement of the dura mater in a recipient during a neurosurgical procedure. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). This dural graft is typically overlaid on the patient's dura. It may be supplied in various sizes and shapes (e.g., square or rectangular) and may be sutured into place.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXQ	DURA SUBSTITUTE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212943	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 5 and 25 Degrees Celsius
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: .
Special Storage Condition, Specify: Protect from heat and radio- active sources

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b937995e-bdcc-405f-a31c-4cc0358e960b
Public Version Date: July 18, 2022
Public Version Number: 2
DI Record Publish Date: May 26, 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: 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)255-2500
Email: xx@xx.xx

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