AccessGUDID - DEVICE: SpaceVision® PLIF (03663136028286)

GUDID

Device Identifier (DI) Information

Brand Name: SpaceVision® PLIF
Version or Model: PL1-C08-21-04
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SPINEVISION

Primary DI Number: 03663136028286
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 390377518 *Terms of Use

Device Description: PLIF cage H08-L21-A04

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):	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?
60766	Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple bacteria associated with respiratory disease in a clinical specimen, including multiple genes conferring antimicrobial resistance in the respiratory isolates detected. Organisms detected may include (but are not limited to) Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila psittaci, C. pneumoniae (Chlamydia pneumoniae), Coxiella burnetii, Legionella pneumophila and/or Bordetella pertussis.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Angle: 04 degree
Length: 21 Millimeter
Height: 08 Millimeter

Device Record Status

Public Device Record Key: 255d0834-5d81-46d0-bc21-dfc75f22ea16
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 07, 2016

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +33153332525
Email: Corp.quality@spinevision.com

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