AccessGUDID - DEVICE: Integra Spetzler™ Lumbar Peritoneal Shunt System (10381780072539)

GUDID

Device Identifier (DI) Information

Brand Name: Integra Spetzler™ Lumbar Peritoneal Shunt System
Version or Model: NL97105S01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NL97105S01
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780072539
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: LONG SPETZLER 105CM LP SHUNT The Spetzler Lumbar Peritoneal Shunt System is designed to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid space to the peritoneum. Due to the small diameter of the catheter tubing, shunting may be accomplished by percutaneous techniques. A variety of devices are available: a one-piece model without a reservoir; separate large or small reservoirs that contain a one-way valve, which may be used when a flushing capability is required; and a separate miter valve, available in low, medium, or high pressure, which may be used when added resistance is desired.

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:	Yes
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?
61523	Lumboperitoneal shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity where it can be absorbed into the body, as a treatment for raised CSF pressure (e.g., caused by hydrocephalus). It consists of fully-implantable interconnected components: a spinal catheter implanted into subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a puncturable port/reservoir for sampling/infusion; a peritoneal catheter implanted into the peritoneal cavity; some types incorporate a subcutaneous anchor for component connection/positioning. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101381	000
K161992	000
K811288	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Cath Dia: 0.7mm I.D. x 1.5mm O.D. (14 gauge): Total Length: 105cm (41.3"); Touhy marked in 1 cm increments up to 12 cm. (All dimensions nominal)

Device Record Status

Public Device Record Key: 755bbac4-2b50-49c9-a208-66a797c3cb7c
Public Version Date: April 07, 2021
Public Version Number: 5
DI Record Publish Date: September 22, 2015