AccessGUDID - DEVICE: NA (20705036004018)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: RLZPT2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RLZPT2
Company Name: Obtech Medical Sàrl

Primary DI Number: 20705036004018
Issuing Agency: GS1
Commercial Distribution End Date: April 13, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 486911852 *Terms of Use

Device Description: Gastric Band Sutureless Port and Applier

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
47065	Gastric band access port kit	A collection of sterile devices designed to establish a replacement access port for an implanted gastric band of the adjustable type that is invasively inflated. It typically includes access port needles, an access port, an end plug, a connector, and tubing to connect the new port to the existing gastric band. It is typically used when the original port must be removed due to leaks, infection, or contamination. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LTI	IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f11c5867-46d2-4010-871c-a6b451332756
Public Version Date: April 14, 2020
Public Version Number: 3
DI Record Publish Date: September 17, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30705036004015	16	20705036004018	2020-04-13	Not in Commercial Distribution	CASE

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

[?]

No Customer Contact currently defined

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